LABELS · 0989d777-c225-46a6-854e-01bdf4f19679

ABRILADA

Open original source → · Download preserved record

Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date: 2026-05-06
Captured: 2026-09-09T23:37:39.774134+00:00
Current indication reconciliation: Not reconciled

Boxed warning in this label

WARNING: SERIOUS INFECTIONS AND MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products, including ABRILADA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) ] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue ABRILADA if a patient develops a serious infection or sepsis. Reported infections include: • Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before ABRILADA use and during therapy. Initiate treatment for latent TB prior to ABRILADA use. • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness. • Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria. Carefully consider the risks and benefits of treatment with ABRILADA prior to initiating therapy in patients with chronic or recurrent infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with ABRILADA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] . MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products [see Warnings and Precautions (5.2) ] . Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all these patients had received treatment with azathioprine or 6-mercaptopurine (6–MP) concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants [see Warnings and Precautions (5.2) ] . WARNING: SERIOUS INFECTIONS AND MALIGNANCY See full prescribing information for complete boxed warning. SERIOUS INFECTIONS ( 5.1 , 6.1 ): • Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. • Discontinue ABRILADA if a patient develops a serious infection or sepsis during treatment. • Perform test for latent TB; if positive, start treatment for TB prior to starting ABRILADA. • Monitor all patients for active TB during treatment, even if initial latent TB test is negative. MALIGNANCY ( 5.2 ): • Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products. • Post‑marketing cases of hepatosplenic T‑cell lymphoma (HSTCL), a rare type of T‑cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF blockers including adalimumab products.

Indications and usage: exact source text

1 INDICATIONS AND USAGE ABRILADA is a tumor necrosis factor (TNF) blocker indicated for: • Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis . ( 1.1 ) • Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. ( 1.2 ) • Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis . ( 1.3 ) • Reducing signs and symptoms in adult patients with active ankylosing spondylitis . ( 1.4 ) • Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. ( 1.5 ) • Treatment of moderately to severely active ulcerative colitis in adult patients. ( 1.6 ) Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. • Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. ( 1.7 ) • Treatment of moderate to severe hidradenitis suppurativa in adult patients. ( 1.8 ) • Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. ( 1.9 ) 1.1 Rheumatoid Arthritis ABRILADA is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. ABRILADA can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). 1.2 Juvenile Idiopathic Arthritis ABRILADA is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. ABRILADA can be used alone or in combination with methotrexate. 1.3 Psoriatic Arthritis ABRILADA is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. ABRILADA can be used alone or in combination with non-biologic DMARDs. 1.4 Ankylosing Spondylitis ABRILADA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. 1.5 Crohn's Disease ABRILADA is indicated for the treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. 1.6 Ulcerative Colitis ABRILADA is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. Limitations of Use The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF blockers [see Clinical Studies (14.7) ] . 1.7 Plaque Psoriasis ABRILADA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. ABRILADA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Warnings and Precautions (5) ] . 1.8 Hidradenitis Suppurativa ABRILADA is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. 1.9 Uveitis ABRILADA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.

Full extracted label fields

application numbers

BLA761118

boxed warning exact

WARNING: SERIOUS INFECTIONS AND MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products, including ABRILADA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) ] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue ABRILADA if a patient develops a serious infection or sepsis. Reported infections include: • Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before ABRILADA use and during therapy. Initiate treatment for latent TB prior to ABRILADA use. • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness. • Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria. Carefully consider the risks and benefits of treatment with ABRILADA prior to initiating therapy in patients with chronic or recurrent infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with ABRILADA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] . MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products [see Warnings and Precautions (5.2) ] . Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all these patients had received treatment with azathioprine or 6-mercaptopurine (6–MP) concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants [see Warnings and Precautions (5.2) ] . WARNING: SERIOUS INFECTIONS AND MALIGNANCY See full prescribing information for complete boxed warning. SERIOUS INFECTIONS ( 5.1 , 6.1 ): • Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. • Discontinue ABRILADA if a patient develops a serious infection or sepsis during treatment. • Perform test for latent TB; if positive, start treatment for TB prior to starting ABRILADA. • Monitor all patients for active TB during treatment, even if initial latent TB test is negative. MALIGNANCY ( 5.2 ): • Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products. • Post‑marketing cases of hepatosplenic T‑cell lymphoma (HSTCL), a rare type of T‑cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF blockers including adalimumab products.

brand names

ABRILADA

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f

generic names

ADALIMUMAB-AFZB

0989d777-c225-46a6-854e-01bdf4f19679

indications and usage exact

1 INDICATIONS AND USAGE ABRILADA is a tumor necrosis factor (TNF) blocker indicated for: • Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis . ( 1.1 ) • Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. ( 1.2 ) • Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis . ( 1.3 ) • Reducing signs and symptoms in adult patients with active ankylosing spondylitis . ( 1.4 ) • Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. ( 1.5 ) • Treatment of moderately to severely active ulcerative colitis in adult patients. ( 1.6 ) Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. • Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. ( 1.7 ) • Treatment of moderate to severe hidradenitis suppurativa in adult patients. ( 1.8 ) • Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. ( 1.9 ) 1.1 Rheumatoid Arthritis ABRILADA is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. ABRILADA can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). 1.2 Juvenile Idiopathic Arthritis ABRILADA is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. ABRILADA can be used alone or in combination with methotrexate. 1.3 Psoriatic Arthritis ABRILADA is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. ABRILADA can be used alone or in combination with non-biologic DMARDs. 1.4 Ankylosing Spondylitis ABRILADA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. 1.5 Crohn's Disease ABRILADA is indicated for the treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. 1.6 Ulcerative Colitis ABRILADA is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. Limitations of Use The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF blockers [see Clinical Studies (14.7) ] . 1.7 Plaque Psoriasis ABRILADA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. ABRILADA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Warnings and Precautions (5) ] . 1.8 Hidradenitis Suppurativa ABRILADA is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. 1.9 Uveitis ABRILADA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.

indications and usage tables exact

is original packager

true

manufacturer names

Pfizer Laboratories Div Pfizer Inc

matched search terms

tumor

package ndcs

0025-0325-01
0025-0325-02
0025-0318-01
0069-1111-01
0025-0328-01
0025-0328-02
0025-0317-01
0025-0333-02
0025-0329-01
0025-0347-02
0025-0331-01
0025-0319-01

product ndcs

0025-0325
0025-0328
0025-0333
0025-0347
0025-0319

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

Warnings and Precautions, Autoimmunity ( 5.9 ) 12/2025

record type

complete_spl_indications_section_candidate

routes

rxcuis

797544
2668064
2668071
2668074
2668078
2668095
2668096
2668105
2668106
2668109
2668113

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00000.json

Source passages and status connections

Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

Passage 1 · indication intro context

application numbers

BLA761118

brand names

ABRILADA

classification reasons

explicit_positive_indication_predicate
tumor_or_malignant_hematology_words_in_positive_statement
incomplete_colon_led_indication_intro

clinical review status

pending

content role

indication_intro_context

context span

end: 288
end exclusive: true
exact text: 1 INDICATIONS AND USAGE ABRILADA is a tumor necrosis factor (TNF) blocker indicated for: • Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 0

current approval status

not_reconciled

duplicate text group

dup-c613fdc563d4288147db

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB-AFZB

ind-span-7a4162d28a9e0a329a9e

label id

0989d777-c225-46a6-854e-01bdf4f19679

positive predicate support span

end: 83
end exclusive: true
exact text: is a tumor necrosis factor (TNF) blocker indicated
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 33

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 88
end exclusive: true
exact text: 1 INDICATIONS AND USAGE ABRILADA is a tumor necrosis factor (TNF) blocker indicated for:
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%220989d777-c225-46a6-854e-01bdf4f19679%22

spl effective date

2026-05-06

spl set id

5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

not_applicable

Passage 2 · positive indication candidate

application numbers

BLA761118

brand names

ABRILADA

classification reasons

inherited_predicate_from_same_label_section_requires_review
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 510
end exclusive: true
exact text: 1 INDICATIONS AND USAGE ABRILADA is a tumor necrosis factor (TNF) blocker indicated for: • Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis . ( 1.1 ) • Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. ( 1.2 ) • Reducing signs and symptoms, inhibit
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 0

current approval status

not_reconciled

duplicate text group

dup-e128c226d4202ae04020

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB-AFZB

ind-span-32e09b073272afb9f293

label id

0989d777-c225-46a6-854e-01bdf4f19679

positive predicate support span

end: 83
end exclusive: true
exact text: is a tumor necrosis factor (TNF) blocker indicated
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 33

qualifier mentions

context exact
on of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis .
kind
age
polarity
not_inferred
span
end
252
end exclusive
true
exact text
adult patients
label id
0989d777-c225-46a6-854e-01bdf4f19679
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start
238

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 310
end exclusive: true
exact text: • Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis .
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 89

source url

https://api.fda.gov/drug/label.json?search=id%3A%220989d777-c225-46a6-854e-01bdf4f19679%22

spl effective date

2026-05-06

spl set id

5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

non_oncology_or_unclear_candidate

Passage 3 · unclassified context

application numbers

BLA761118

brand names

ABRILADA

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 518
end exclusive: true
exact text: ymptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis . ( 1.1 ) • Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. ( 1.2 ) • Reducing signs and symptoms, inhibiting the
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 111

current approval status

not_reconciled

duplicate text group

dup-db42e2f0f9023f240aa3

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB-AFZB

ind-span-e2156b1766a5a23d95f8

label id

0989d777-c225-46a6-854e-01bdf4f19679

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 318
end exclusive: true
exact text: ( 1.1 )
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 311

source url

https://api.fda.gov/drug/label.json?search=id%3A%220989d777-c225-46a6-854e-01bdf4f19679%22

spl effective date

2026-05-06

spl set id

5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 4 · unclassified context

application numbers

BLA761118

brand names

ABRILADA

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 663
end exclusive: true
exact text: inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis . ( 1.1 ) • Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. ( 1.2 ) • Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis . ( 1.3 ) • Reducing signs an
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 119

current approval status

not_reconciled

duplicate text group

dup-80146ce18c0aa7e784b1

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB-AFZB

ind-span-48a907db37dcf67cc9d2

label id

0989d777-c225-46a6-854e-01bdf4f19679

positive predicate support span

Source null

qualifier mentions

context exact
ive polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.
kind
age
polarity
not_inferred
span
end
452
end exclusive
true
exact text
2 years of age
label id
0989d777-c225-46a6-854e-01bdf4f19679
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start
438

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 463
end exclusive: true
exact text: • Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 319

source url

https://api.fda.gov/drug/label.json?search=id%3A%220989d777-c225-46a6-854e-01bdf4f19679%22

spl effective date

2026-05-06

spl set id

5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 5 · unclassified context

application numbers

BLA761118

brand names

ABRILADA

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 671
end exclusive: true
exact text: tely to severely active rheumatoid arthritis . ( 1.1 ) • Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. ( 1.2 ) • Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis . ( 1.3 ) • Reducing signs and sympto
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 264

current approval status

not_reconciled

duplicate text group

dup-3a2caed300c9993d324c

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB-AFZB

ind-span-df3b0eef63e7798715f6

label id

0989d777-c225-46a6-854e-01bdf4f19679

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 471
end exclusive: true
exact text: ( 1.2 )
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 464

source url

https://api.fda.gov/drug/label.json?search=id%3A%220989d777-c225-46a6-854e-01bdf4f19679%22

spl effective date

2026-05-06

spl set id

5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 6 · positive indication candidate

application numbers

BLA761118

brand names

ABRILADA

classification reasons

inherited_predicate_from_same_label_section_requires_review
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 835
end exclusive: true
exact text: severely active rheumatoid arthritis . ( 1.1 ) • Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. ( 1.2 ) • Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis . ( 1.3 ) • Reducing signs and symptoms in adult patients with active ankylosing spondylitis . ( 1.4 ) • Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 ye
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 272

current approval status

not_reconciled

duplicate text group

dup-5876bc31d149976c5f1d

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB-AFZB

ind-span-6a31d698d75fe6d02c4f

label id

0989d777-c225-46a6-854e-01bdf4f19679

positive predicate support span

end: 83
end exclusive: true
exact text: is a tumor necrosis factor (TNF) blocker indicated
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 33

qualifier mentions

context exact
on of structural damage, and improving physical function in adult patients with active psoriatic arthritis .
kind
age
polarity
not_inferred
span
end
601
end exclusive
true
exact text
adult patients
label id
0989d777-c225-46a6-854e-01bdf4f19679
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start
587

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 635
end exclusive: true
exact text: • Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis .
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 472

source url

https://api.fda.gov/drug/label.json?search=id%3A%220989d777-c225-46a6-854e-01bdf4f19679%22

spl effective date

2026-05-06

spl set id

5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

non_oncology_or_unclear_candidate

Passage 7 · unclassified context

application numbers

BLA761118

brand names

ABRILADA

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 843
end exclusive: true
exact text: s 2 years of age and older. ( 1.2 ) • Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis . ( 1.3 ) • Reducing signs and symptoms in adult patients with active ankylosing spondylitis . ( 1.4 ) • Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of a
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 436

current approval status

not_reconciled

duplicate text group

dup-3c4e182bc469a6a74f4e

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB-AFZB

ind-span-f5760cbb316e0b175883

label id

0989d777-c225-46a6-854e-01bdf4f19679

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 643
end exclusive: true
exact text: ( 1.3 )
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 636

source url

https://api.fda.gov/drug/label.json?search=id%3A%220989d777-c225-46a6-854e-01bdf4f19679%22

spl effective date

2026-05-06

spl set id

5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 8 · positive indication candidate

application numbers

BLA761118

brand names

ABRILADA

classification reasons

inherited_predicate_from_same_label_section_requires_review
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 928
end exclusive: true
exact text: s of age and older. ( 1.2 ) • Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis . ( 1.3 ) • Reducing signs and symptoms in adult patients with active ankylosing spondylitis . ( 1.4 ) • Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. ( 1.5 ) • Treatment of moderately to severely active ulcerative colitis
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 444

current approval status

not_reconciled

duplicate text group

dup-92ac53865e206a2b2255

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB-AFZB

ind-span-914d5f4719340e06fc28

label id

0989d777-c225-46a6-854e-01bdf4f19679

positive predicate support span

end: 83
end exclusive: true
exact text: is a tumor necrosis factor (TNF) blocker indicated
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 33

qualifier mentions

context exact
• Reducing signs and symptoms in adult patients with active ankylosing spondylitis .
kind
age
polarity
not_inferred
span
end
691
end exclusive
true
exact text
adult patients
label id
0989d777-c225-46a6-854e-01bdf4f19679
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start
677

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 728
end exclusive: true
exact text: • Reducing signs and symptoms in adult patients with active ankylosing spondylitis .
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 644

source url

https://api.fda.gov/drug/label.json?search=id%3A%220989d777-c225-46a6-854e-01bdf4f19679%22

spl effective date

2026-05-06

spl set id

5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

non_oncology_or_unclear_candidate

Passage 9 · unclassified context

application numbers

BLA761118

brand names

ABRILADA

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 936
end exclusive: true
exact text: of structural damage, and improving physical function in adult patients with active psoriatic arthritis . ( 1.3 ) • Reducing signs and symptoms in adult patients with active ankylosing spondylitis . ( 1.4 ) • Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. ( 1.5 ) • Treatment of moderately to severely active ulcerative colitis in adul
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 529

current approval status

not_reconciled

duplicate text group

dup-df1c214ba6f9d08c4242

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB-AFZB

ind-span-b9c1cdd365e8f96ba71c

label id

0989d777-c225-46a6-854e-01bdf4f19679

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 736
end exclusive: true
exact text: ( 1.4 )
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 729

source url

https://api.fda.gov/drug/label.json?search=id%3A%220989d777-c225-46a6-854e-01bdf4f19679%22

spl effective date

2026-05-06

spl set id

5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 10 · unclassified context

application numbers

BLA761118

brand names

ABRILADA

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1056
end exclusive: true
exact text: ctural damage, and improving physical function in adult patients with active psoriatic arthritis . ( 1.3 ) • Reducing signs and symptoms in adult patients with active ankylosing spondylitis . ( 1.4 ) • Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. ( 1.5 ) • Treatment of moderately to severely active ulcerative colitis in adult patients. ( 1.6 ) Limitations of Use: Effectiveness has not been established in patients who have lost response to or
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 537

current approval status

not_reconciled

duplicate text group

dup-4b55b9c78fd83d7cf7a6

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB-AFZB

ind-span-ac63435e1936cbf44956

label id

0989d777-c225-46a6-854e-01bdf4f19679

positive predicate support span

Source null

qualifier mentions

context exact
eatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
kind
age
polarity
not_inferred
span
end
807
end exclusive
true
exact text
adults
label id
0989d777-c225-46a6-854e-01bdf4f19679
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start
801
context exact
moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
kind
age
polarity
not_inferred
span
end
830
end exclusive
true
exact text
pediatric patients
label id
0989d777-c225-46a6-854e-01bdf4f19679
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start
812
context exact
ely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
kind
age
polarity
not_inferred
span
end
845
end exclusive
true
exact text
6 years of age
label id
0989d777-c225-46a6-854e-01bdf4f19679
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start
831

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 856
end exclusive: true
exact text: • Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 737

source url

https://api.fda.gov/drug/label.json?search=id%3A%220989d777-c225-46a6-854e-01bdf4f19679%22

spl effective date

2026-05-06

spl set id

5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 11 · unclassified context

application numbers

BLA761118

brand names

ABRILADA

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1064
end exclusive: true
exact text: gns and symptoms in adult patients with active ankylosing spondylitis . ( 1.4 ) • Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. ( 1.5 ) • Treatment of moderately to severely active ulcerative colitis in adult patients. ( 1.6 ) Limitations of Use: Effectiveness has not been established in patients who have lost response to or were int
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 657

current approval status

not_reconciled

duplicate text group

dup-3ebb28ee0e056f114bda

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB-AFZB

ind-span-6477dab0b7bc711c5fd9

label id

0989d777-c225-46a6-854e-01bdf4f19679

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 864
end exclusive: true
exact text: ( 1.5 )
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 857

source url

https://api.fda.gov/drug/label.json?search=id%3A%220989d777-c225-46a6-854e-01bdf4f19679%22

spl effective date

2026-05-06

spl set id

5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 12 · unclassified context

application numbers

BLA761118

brand names

ABRILADA

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1147
end exclusive: true
exact text: symptoms in adult patients with active ankylosing spondylitis . ( 1.4 ) • Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. ( 1.5 ) • Treatment of moderately to severely active ulcerative colitis in adult patients. ( 1.6 ) Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. • Treatment of adult patients with moderate to severe chro
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 665

current approval status

not_reconciled

duplicate text group

dup-3966f1c6a36b188cc60a

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB-AFZB

ind-span-dafc40b43f2493f5ca32

label id

0989d777-c225-46a6-854e-01bdf4f19679

positive predicate support span

Source null

qualifier mentions

context exact
ment of moderately to severely active ulcerative colitis in adult patients.
kind
age
polarity
not_inferred
span
end
946
end exclusive
true
exact text
adult patients
label id
0989d777-c225-46a6-854e-01bdf4f19679
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start
932

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 947
end exclusive: true
exact text: • Treatment of moderately to severely active ulcerative colitis in adult patients.
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 865

source url

https://api.fda.gov/drug/label.json?search=id%3A%220989d777-c225-46a6-854e-01bdf4f19679%22

spl effective date

2026-05-06

spl set id

5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 13 · limitation of use

application numbers

BLA761118

brand names

ABRILADA

classification reasons

negative_or_not_established_clause

clinical review status

pending

content role

limitation_of_use

context span

end: 1288
end exclusive: true
exact text: of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. ( 1.5 ) • Treatment of moderately to severely active ulcerative colitis in adult patients. ( 1.6 ) Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. • Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriat
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 748

current approval status

not_reconciled

duplicate text group

dup-625cc4941e675a7052c4

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB-AFZB

ind-span-96114d9b487083dca81b

label id

0989d777-c225-46a6-854e-01bdf4f19679

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 1088
end exclusive: true
exact text: ( 1.6 ) Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers.
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 948

source url

https://api.fda.gov/drug/label.json?search=id%3A%220989d777-c225-46a6-854e-01bdf4f19679%22

spl effective date

2026-05-06

spl set id

5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

not_applicable

Passage 14 · unclassified context

application numbers

BLA761118

brand names

ABRILADA

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1490
end exclusive: true
exact text: y to severely active ulcerative colitis in adult patients. ( 1.6 ) Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. • Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. ( 1.7 ) • Treatment of moderate to severe hidradenitis suppurativa in adult patients. ( 1.8 ) • Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. ( 1.9 ) 1.1 Rheu
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 889

current approval status

not_reconciled

duplicate text group

dup-affc84cd213aa89a9ed7

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB-AFZB

ind-span-2e65bb479df36d19fcea

label id

0989d777-c225-46a6-854e-01bdf4f19679

positive predicate support span

Source null

qualifier mentions

context exact
• Treatment of adult patients with moderate to severe chronic plaque psoriasis who are ca
kind
age
polarity
not_inferred
span
end
1118
end exclusive
true
exact text
adult patients
label id
0989d777-c225-46a6-854e-01bdf4f19679
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start
1104

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 1290
end exclusive: true
exact text: • Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 1089

source url

https://api.fda.gov/drug/label.json?search=id%3A%220989d777-c225-46a6-854e-01bdf4f19679%22

spl effective date

2026-05-06

spl set id

5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 15 · unclassified context

application numbers

BLA761118

brand names

ABRILADA

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1498
end exclusive: true
exact text: Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. ( 1.7 ) • Treatment of moderate to severe hidradenitis suppurativa in adult patients. ( 1.8 ) • Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. ( 1.9 ) 1.1 Rheumatoid A
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 1091

current approval status

not_reconciled

duplicate text group

dup-0d4fc793c9981859926e

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB-AFZB

ind-span-13e9da65906ab4a3328b

label id

0989d777-c225-46a6-854e-01bdf4f19679

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 1298
end exclusive: true
exact text: ( 1.7 )
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 1291

source url

https://api.fda.gov/drug/label.json?search=id%3A%220989d777-c225-46a6-854e-01bdf4f19679%22

spl effective date

2026-05-06

spl set id

5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 16 · unclassified context

application numbers

BLA761118

brand names

ABRILADA

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1576
end exclusive: true
exact text: t of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. ( 1.7 ) • Treatment of moderate to severe hidradenitis suppurativa in adult patients. ( 1.8 ) • Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. ( 1.9 ) 1.1 Rheumatoid Arthritis ABRILADA is indicated for reducing signs and symptoms, inducing major
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 1099

current approval status

not_reconciled

duplicate text group

dup-b11d7ad9640946f83b43

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB-AFZB

ind-span-0367fb24b6c27b3e550a

label id

0989d777-c225-46a6-854e-01bdf4f19679

positive predicate support span

Source null

qualifier mentions

context exact
Treatment of moderate to severe hidradenitis suppurativa in adult patients.
kind
age
polarity
not_inferred
span
end
1375
end exclusive
true
exact text
adult patients
label id
0989d777-c225-46a6-854e-01bdf4f19679
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start
1361

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 1376
end exclusive: true
exact text: • Treatment of moderate to severe hidradenitis suppurativa in adult patients.
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 1299

source url

https://api.fda.gov/drug/label.json?search=id%3A%220989d777-c225-46a6-854e-01bdf4f19679%22

spl effective date

2026-05-06

spl set id

5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 17 · unclassified context

application numbers

BLA761118

brand names

ABRILADA

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1584
end exclusive: true
exact text: andidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. ( 1.7 ) • Treatment of moderate to severe hidradenitis suppurativa in adult patients. ( 1.8 ) • Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. ( 1.9 ) 1.1 Rheumatoid Arthritis ABRILADA is indicated for reducing signs and symptoms, inducing major clinica
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 1177

current approval status

not_reconciled

duplicate text group

dup-3bb410f4abc063674908

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB-AFZB

ind-span-156b5dbd23cdc4c55b98

label id

0989d777-c225-46a6-854e-01bdf4f19679

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 1384
end exclusive: true
exact text: ( 1.8 )
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 1377

source url

https://api.fda.gov/drug/label.json?search=id%3A%220989d777-c225-46a6-854e-01bdf4f19679%22

spl effective date

2026-05-06

spl set id

5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 18 · unclassified context

application numbers

BLA761118

brand names

ABRILADA

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1673
end exclusive: true
exact text: s for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. ( 1.7 ) • Treatment of moderate to severe hidradenitis suppurativa in adult patients. ( 1.8 ) • Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. ( 1.9 ) 1.1 Rheumatoid Arthritis ABRILADA is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical funct
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 1185

current approval status

not_reconciled

duplicate text group

dup-8081fdaf264814bb8e8a

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB-AFZB

ind-span-c7164df54baea035f923

label id

0989d777-c225-46a6-854e-01bdf4f19679

positive predicate support span

Source null

qualifier mentions

context exact
f non-infectious intermediate, posterior, and panuveitis in adult patients.
kind
age
polarity
not_inferred
span
end
1472
end exclusive
true
exact text
adult patients
label id
0989d777-c225-46a6-854e-01bdf4f19679
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start
1458

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 1473
end exclusive: true
exact text: • Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 1385

source url

https://api.fda.gov/drug/label.json?search=id%3A%220989d777-c225-46a6-854e-01bdf4f19679%22

spl effective date

2026-05-06

spl set id

5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 19 · unclassified context

application numbers

BLA761118

brand names

ABRILADA

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1681
end exclusive: true
exact text: ess appropriate. ( 1.7 ) • Treatment of moderate to severe hidradenitis suppurativa in adult patients. ( 1.8 ) • Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. ( 1.9 ) 1.1 Rheumatoid Arthritis ABRILADA is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in a
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 1274

current approval status

not_reconciled

duplicate text group

dup-da50c190e96bcd356b0b

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB-AFZB

ind-span-16b4c929cd45600061e3

label id

0989d777-c225-46a6-854e-01bdf4f19679

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 1481
end exclusive: true
exact text: ( 1.9 )
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 1474

source url

https://api.fda.gov/drug/label.json?search=id%3A%220989d777-c225-46a6-854e-01bdf4f19679%22

spl effective date

2026-05-06

spl set id

5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 20 · positive indication candidate

application numbers

BLA761118

brand names

ABRILADA

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 1951
end exclusive: true
exact text: opriate. ( 1.7 ) • Treatment of moderate to severe hidradenitis suppurativa in adult patients. ( 1.8 ) • Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. ( 1.9 ) 1.1 Rheumatoid Arthritis ABRILADA is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. ABRILADA can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). 1.2 Juvenile Idiopathic Arthritis ABRILADA is indicated for reduc
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 1282

current approval status

not_reconciled

duplicate text group

dup-b91aa7f99fd72532c87f

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB-AFZB

ind-span-e23c5500aefb28481697

label id

0989d777-c225-46a6-854e-01bdf4f19679

positive predicate support span

end: 1528
end exclusive: true
exact text: is indicated
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 1516

qualifier mentions

context exact
on of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis.
kind
age
polarity
not_inferred
span
end
1694
end exclusive
true
exact text
adult patients
label id
0989d777-c225-46a6-854e-01bdf4f19679
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start
1680

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 1751
end exclusive: true
exact text: 1.1 Rheumatoid Arthritis ABRILADA is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis.
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 1482

source url

https://api.fda.gov/drug/label.json?search=id%3A%220989d777-c225-46a6-854e-01bdf4f19679%22

spl effective date

2026-05-06

spl set id

5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

non_oncology_or_unclear_candidate

Passage 21 · unclassified context

application numbers

BLA761118

brand names

ABRILADA

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 2085
end exclusive: true
exact text: symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. ABRILADA can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). 1.2 Juvenile Idiopathic Arthritis ABRILADA is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and old
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 1552

current approval status

not_reconciled

duplicate text group

dup-074b9b08046173697334

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB-AFZB

ind-span-575564a9d4f2b3ece14d

label id

0989d777-c225-46a6-854e-01bdf4f19679

positive predicate support span

Source null

qualifier mentions

context exact
ABRILADA can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).
kind
biomarker
polarity
not_inferred
span
end
1845
end exclusive
true
exact text
methotrexate or other non-biologic disease-
label id
0989d777-c225-46a6-854e-01bdf4f19679
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start
1802
context exact
ABRILADA can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).
kind
regimen
polarity
not_inferred
span
end
1884
end exclusive
true
exact text
in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs)
label id
0989d777-c225-46a6-854e-01bdf4f19679
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start
1782

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 1885
end exclusive: true
exact text: ABRILADA can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 1752

source url

https://api.fda.gov/drug/label.json?search=id%3A%220989d777-c225-46a6-854e-01bdf4f19679%22

spl effective date

2026-05-06

spl set id

5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 22 · positive indication candidate

application numbers

BLA761118

brand names

ABRILADA

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 2288
end exclusive: true
exact text: patients with moderately to severely active rheumatoid arthritis. ABRILADA can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). 1.2 Juvenile Idiopathic Arthritis ABRILADA is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. ABRILADA can be used alone or in combination with methotrexate. 1.3 Psoriatic Arthritis ABRILADA is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and imp
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 1686

current approval status

not_reconciled

duplicate text group

dup-db058f2a110583697384

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB-AFZB

ind-span-711b572e5c3b6dcc0ef9

label id

0989d777-c225-46a6-854e-01bdf4f19679

positive predicate support span

end: 1941
end exclusive: true
exact text: is indicated
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 1929

qualifier mentions

context exact
ive polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.
kind
age
polarity
not_inferred
span
end
2077
end exclusive
true
exact text
2 years of age
label id
0989d777-c225-46a6-854e-01bdf4f19679
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start
2063

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 2088
end exclusive: true
exact text: 1.2 Juvenile Idiopathic Arthritis ABRILADA is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 1886

source url

https://api.fda.gov/drug/label.json?search=id%3A%220989d777-c225-46a6-854e-01bdf4f19679%22

spl effective date

2026-05-06

spl set id

5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

non_oncology_or_unclear_candidate

Passage 23 · unclassified context

application numbers

BLA761118

brand names

ABRILADA

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 2352
end exclusive: true
exact text: Juvenile Idiopathic Arthritis ABRILADA is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. ABRILADA can be used alone or in combination with methotrexate. 1.3 Psoriatic Arthritis ABRILADA is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 1889

current approval status

not_reconciled

duplicate text group

dup-652a4bb6dd8c1541297d

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB-AFZB

ind-span-8513d30c3d9533f821ce

label id

0989d777-c225-46a6-854e-01bdf4f19679

positive predicate support span

Source null

qualifier mentions

context exact
ABRILADA can be used alone or in combination with methotrexate.
kind
biomarker
polarity
not_inferred
span
end
2151
end exclusive
true
exact text
methotrexate
label id
0989d777-c225-46a6-854e-01bdf4f19679
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start
2139
context exact
ABRILADA can be used alone or in combination with methotrexate.
kind
regimen
polarity
not_inferred
span
end
2151
end exclusive
true
exact text
in combination with methotrexate
label id
0989d777-c225-46a6-854e-01bdf4f19679
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start
2119

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 2152
end exclusive: true
exact text: ABRILADA can be used alone or in combination with methotrexate.
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 2089

source url

https://api.fda.gov/drug/label.json?search=id%3A%220989d777-c225-46a6-854e-01bdf4f19679%22

spl effective date

2026-05-06

spl set id

5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 24 · positive indication candidate

application numbers

BLA761118

brand names

ABRILADA

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 2563
end exclusive: true
exact text: g signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. ABRILADA can be used alone or in combination with methotrexate. 1.3 Psoriatic Arthritis ABRILADA is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. ABRILADA can be used alone or in combination with non-biologic DMARDs. 1.4 Ankylosing Spondylitis ABRILADA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondy
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 1953

current approval status

not_reconciled

duplicate text group

dup-44779559e165b4ab9029

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB-AFZB

ind-span-eaee8d831dc102fb5101

label id

0989d777-c225-46a6-854e-01bdf4f19679

positive predicate support span

end: 2198
end exclusive: true
exact text: is indicated
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 2186

qualifier mentions

context exact
on of structural damage, and improving physical function in adult patients with active psoriatic arthritis.
kind
age
polarity
not_inferred
span
end
2330
end exclusive
true
exact text
adult patients
label id
0989d777-c225-46a6-854e-01bdf4f19679
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start
2316

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 2363
end exclusive: true
exact text: 1.3 Psoriatic Arthritis ABRILADA is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis.
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 2153

source url

https://api.fda.gov/drug/label.json?search=id%3A%220989d777-c225-46a6-854e-01bdf4f19679%22

spl effective date

2026-05-06

spl set id

5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

non_oncology_or_unclear_candidate

Passage 25 · unclassified context

application numbers

BLA761118

brand names

ABRILADA

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 2634
end exclusive: true
exact text: ic Arthritis ABRILADA is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. ABRILADA can be used alone or in combination with non-biologic DMARDs. 1.4 Ankylosing Spondylitis ABRILADA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. 1.5 Crohn's Disease ABRILADA is indicated for the treatment of m
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 2164

current approval status

not_reconciled

duplicate text group

dup-3b602608b97a7104f06e

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB-AFZB

ind-span-2ffa69c1ab5b1f19b32f

label id

0989d777-c225-46a6-854e-01bdf4f19679

positive predicate support span

Source null

qualifier mentions

context exact
ABRILADA can be used alone or in combination with non-biologic DMARDs.
kind
regimen
polarity
not_inferred
span
end
2433
end exclusive
true
exact text
in combination with non-biologic DMARDs
label id
0989d777-c225-46a6-854e-01bdf4f19679
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start
2394

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 2434
end exclusive: true
exact text: ABRILADA can be used alone or in combination with non-biologic DMARDs.
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 2364

source url

https://api.fda.gov/drug/label.json?search=id%3A%220989d777-c225-46a6-854e-01bdf4f19679%22

spl effective date

2026-05-06

spl set id

5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 26 · positive indication candidate

application numbers

BLA761118

brand names

ABRILADA

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 2769
end exclusive: true
exact text: ibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. ABRILADA can be used alone or in combination with non-biologic DMARDs. 1.4 Ankylosing Spondylitis ABRILADA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. 1.5 Crohn's Disease ABRILADA is indicated for the treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. 1.6 Ulcerative Colitis ABRILADA
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 2235

current approval status

not_reconciled

duplicate text group

dup-7b3c883e5cd0b040e49f

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB-AFZB

ind-span-1ef74f82acf82c719f43

label id

0989d777-c225-46a6-854e-01bdf4f19679

positive predicate support span

end: 2483
end exclusive: true
exact text: is indicated
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 2471

qualifier mentions

context exact
is ABRILADA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.
kind
age
polarity
not_inferred
span
end
2533
end exclusive
true
exact text
adult patients
label id
0989d777-c225-46a6-854e-01bdf4f19679
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start
2519

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 2569
end exclusive: true
exact text: 1.4 Ankylosing Spondylitis ABRILADA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 2435

source url

https://api.fda.gov/drug/label.json?search=id%3A%220989d777-c225-46a6-854e-01bdf4f19679%22

spl effective date

2026-05-06

spl set id

5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

non_oncology_or_unclear_candidate

Passage 27 · positive indication candidate

application numbers

BLA761118

brand names

ABRILADA

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 2937
end exclusive: true
exact text: DA can be used alone or in combination with non-biologic DMARDs. 1.4 Ankylosing Spondylitis ABRILADA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. 1.5 Crohn's Disease ABRILADA is indicated for the treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. 1.6 Ulcerative Colitis ABRILADA is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. Limitations of Use The effectiveness of adalimumab products has n
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 2370

current approval status

not_reconciled

duplicate text group

dup-8d3cc4823c5e9f686f6e

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB-AFZB

ind-span-f9d820f0fa4bd3a8ca0e

label id

0989d777-c225-46a6-854e-01bdf4f19679

positive predicate support span

end: 2611
end exclusive: true
exact text: is indicated
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 2599

qualifier mentions

context exact
eatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older.
kind
age
polarity
not_inferred
span
end
2688
end exclusive
true
exact text
adults
label id
0989d777-c225-46a6-854e-01bdf4f19679
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start
2682
context exact
moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older.
kind
age
polarity
not_inferred
span
end
2711
end exclusive
true
exact text
pediatric patients
label id
0989d777-c225-46a6-854e-01bdf4f19679
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start
2693
context exact
ely active Crohn's disease in adults and pediatric patients 6 years of age and older.
kind
age
polarity
not_inferred
span
end
2726
end exclusive
true
exact text
6 years of age
label id
0989d777-c225-46a6-854e-01bdf4f19679
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start
2712

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 2737
end exclusive: true
exact text: 1.5 Crohn's Disease ABRILADA is indicated for the treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older.
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 2570

source url

https://api.fda.gov/drug/label.json?search=id%3A%220989d777-c225-46a6-854e-01bdf4f19679%22

spl effective date

2026-05-06

spl set id

5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

non_oncology_or_unclear_candidate

Passage 28 · positive indication candidate

application numbers

BLA761118

brand names

ABRILADA

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 3071
end exclusive: true
exact text: active ankylosing spondylitis. 1.5 Crohn's Disease ABRILADA is indicated for the treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. 1.6 Ulcerative Colitis ABRILADA is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. Limitations of Use The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF blockers [see Clinical Studies (14.7) ] . 1.7 Plaq
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 2538

current approval status

not_reconciled

duplicate text group

dup-6d136a4936c18dd1cfac

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB-AFZB

ind-span-d4e1ec3025200b4b937a

label id

0989d777-c225-46a6-854e-01bdf4f19679

positive predicate support span

end: 2782
end exclusive: true
exact text: is indicated
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 2770

qualifier mentions

context exact
ment of moderately to severely active ulcerative colitis in adult patients.
kind
age
polarity
not_inferred
span
end
2870
end exclusive
true
exact text
adult patients
label id
0989d777-c225-46a6-854e-01bdf4f19679
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start
2856

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 2871
end exclusive: true
exact text: 1.6 Ulcerative Colitis ABRILADA is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients.
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 2738

source url

https://api.fda.gov/drug/label.json?search=id%3A%220989d777-c225-46a6-854e-01bdf4f19679%22

spl effective date

2026-05-06

spl set id

5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

non_oncology_or_unclear_candidate

Passage 29 · limitation of use

application numbers

BLA761118

brand names

ABRILADA

classification reasons

negative_or_not_established_clause

clinical review status

pending

content role

limitation_of_use

context span

end: 3262
end exclusive: true
exact text: isease in adults and pediatric patients 6 years of age and older. 1.6 Ulcerative Colitis ABRILADA is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. Limitations of Use The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF blockers [see Clinical Studies (14.7) ] . 1.7 Plaque Psoriasis ABRILADA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 2672

current approval status

not_reconciled

duplicate text group

dup-493fc4aef75724754742

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB-AFZB

ind-span-0116fdca2a75c3973a2d

label id

0989d777-c225-46a6-854e-01bdf4f19679

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 3062
end exclusive: true
exact text: Limitations of Use The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF blockers [see Clinical Studies (14.7) ] .
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 2872

source url

https://api.fda.gov/drug/label.json?search=id%3A%220989d777-c225-46a6-854e-01bdf4f19679%22

spl effective date

2026-05-06

spl set id

5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

not_applicable

Passage 30 · positive indication candidate

application numbers

BLA761118

brand names

ABRILADA

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 3513
end exclusive: true
exact text: atients. Limitations of Use The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF blockers [see Clinical Studies (14.7) ] . 1.7 Plaque Psoriasis ABRILADA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. ABRILADA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Warnings and Precautions (5) ] . 1.8 Hidradenitis Suppurativa AB
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 2863

current approval status

not_reconciled

duplicate text group

dup-97082655951431eb998e

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB-AFZB

ind-span-8544c7ab5c818aa16a57

label id

0989d777-c225-46a6-854e-01bdf4f19679

positive predicate support span

end: 3105
end exclusive: true
exact text: is indicated
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 3093

qualifier mentions

context exact
Plaque Psoriasis ABRILADA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are ca
kind
age
polarity
not_inferred
span
end
3141
end exclusive
true
exact text
adult patients
label id
0989d777-c225-46a6-854e-01bdf4f19679
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start
3127

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 3313
end exclusive: true
exact text: 1.7 Plaque Psoriasis ABRILADA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 3063

source url

https://api.fda.gov/drug/label.json?search=id%3A%220989d777-c225-46a6-854e-01bdf4f19679%22

spl effective date

2026-05-06

spl set id

5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

non_oncology_or_unclear_candidate

Passage 31 · risk or warning

application numbers

BLA761118

brand names

ABRILADA

classification reasons

risk_or_warning_words_without_positive_predicate

clinical review status

pending

content role

risk_or_warning

context span

end: 3681
end exclusive: true
exact text: treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. ABRILADA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Warnings and Precautions (5) ] . 1.8 Hidradenitis Suppurativa ABRILADA is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. 1.9 Uveitis ABRILADA is indicated for the treatment of non-infec
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 3114

current approval status

not_reconciled

duplicate text group

dup-854c7faa7c9a063b85b6

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB-AFZB

ind-span-84abab07cb8ade2aa24f

label id

0989d777-c225-46a6-854e-01bdf4f19679

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 3481
end exclusive: true
exact text: ABRILADA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Warnings and Precautions (5) ] .
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 3314

source url

https://api.fda.gov/drug/label.json?search=id%3A%220989d777-c225-46a6-854e-01bdf4f19679%22

spl effective date

2026-05-06

spl set id

5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

not_applicable

Passage 32 · positive indication candidate

application numbers

BLA761118

brand names

ABRILADA

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 3745
end exclusive: true
exact text: are medically less appropriate. ABRILADA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Warnings and Precautions (5) ] . 1.8 Hidradenitis Suppurativa ABRILADA is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. 1.9 Uveitis ABRILADA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 3282

current approval status

not_reconciled

duplicate text group

dup-263b09cbf340acea94db

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB-AFZB

ind-span-abd7869c3fcc8e3b4d0a

label id

0989d777-c225-46a6-854e-01bdf4f19679

positive predicate support span

end: 3532
end exclusive: true
exact text: is indicated
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 3520

qualifier mentions

context exact
treatment of moderate to severe hidradenitis suppurativa in adult patients.
kind
age
polarity
not_inferred
span
end
3615
end exclusive
true
exact text
adult patients
label id
0989d777-c225-46a6-854e-01bdf4f19679
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start
3601

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 3616
end exclusive: true
exact text: 1.8 Hidradenitis Suppurativa ABRILADA is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients.
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 3482

source url

https://api.fda.gov/drug/label.json?search=id%3A%220989d777-c225-46a6-854e-01bdf4f19679%22

spl effective date

2026-05-06

spl set id

5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

non_oncology_or_unclear_candidate

Passage 33 · positive indication candidate

application numbers

BLA761118

brand names

ABRILADA

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 3745
end exclusive: true
exact text: up visits with a physician [see Warnings and Precautions (5) ] . 1.8 Hidradenitis Suppurativa ABRILADA is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. 1.9 Uveitis ABRILADA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 3417

current approval status

not_reconciled

duplicate text group

dup-862bf7a0b1595fca150b

extraction review status

automated_candidate_pending_source_review

generic names

ADALIMUMAB-AFZB

ind-span-c5e43483e39aa2e93dec

label id

0989d777-c225-46a6-854e-01bdf4f19679

positive predicate support span

end: 3650
end exclusive: true
exact text: is indicated
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 3638

qualifier mentions

context exact
f non-infectious intermediate, posterior, and panuveitis in adult patients.
kind
age
polarity
not_inferred
span
end
3744
end exclusive
true
exact text
adult patients
label id
0989d777-c225-46a6-854e-01bdf4f19679
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start
3730

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 3745
end exclusive: true
exact text: 1.9 Uveitis ABRILADA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.
label id: 0989d777-c225-46a6-854e-01bdf4f19679
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 3827d8bebe0d3cb8b811dad5d7bf100f7952771cb0690cfb46399fdb3f31884d
start: 3617

source url

https://api.fda.gov/drug/label.json?search=id%3A%220989d777-c225-46a6-854e-01bdf4f19679%22

spl effective date

2026-05-06

spl set id

5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

non_oncology_or_unclear_candidate

Preserved source evidence · Not medical advice