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LABELS · fa5fba33-fd55-4011-8871-2c2013b5a0e4

ABRILADA

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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
2026-06-18
Captured
2026-09-09T23:38:04.335995+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. 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. 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
  1. BLA761118
boxed warning exact
  1. 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
  1. ABRILADA
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=79943fe6-1249-4074-9aed-c53937820d0f
generic names
  1. ADALIMUMAB-AFZB
id
fa5fba33-fd55-4011-8871-2c2013b5a0e4
indications and usage exact
  1. 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
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              1. Active Ingredient
                ADALIMUMAB-AFZB
                Appl No
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            Source passages and status connections

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            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
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                  1 INDICATIONS AND USAGE ABRILADA is a tumor necrosis factor (TNF) blocker indicated for:
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                                                                                                                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.
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                                                                                                                    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
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                                                                                                                            application numbers
                                                                                                                            1. BLA761118
                                                                                                                            brand names
                                                                                                                            1. ABRILADA
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                                                                                                                            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
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                                                                                                                              on of structural damage, and improving physical function in adult patients with active psoriatic arthritis.
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                                                                                                                                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.
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                                                                                                                                application numbers
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                                                                                                                                brand names
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                                                                                                                                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
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                                                                                                                                    application numbers
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                                                                                                                                    brand names
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                                                                                                                                    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
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                                                                                                                                    qualifier mentions
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                                                                                                                                        1.4 Ankylosing Spondylitis ABRILADA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.
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                                                                                                                                        brand names
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                                                                                                                                        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
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                                                                                                                                          eatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older.
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                                                                                                                                          age
                                                                                                                                          polarity
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                                                                                                                                          moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older.
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                                                                                                                                          age
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                                                                                                                                            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.
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                                                                                                                                            brand names
                                                                                                                                            1. ABRILADA
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                                                                                                                                            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
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                                                                                                                                                1.6 Ulcerative Colitis ABRILADA is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients.
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                                                                                                                                                application numbers
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                                                                                                                                                brand names
                                                                                                                                                1. ABRILADA
                                                                                                                                                classification reasons
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                                                                                                                                                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
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                                                                                                                                                      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) ] .
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                                                                                                                                                      application numbers
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                                                                                                                                                      brand names
                                                                                                                                                      1. ABRILADA
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                                                                                                                                                      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
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                                                                                                                                                      1. context exact
                                                                                                                                                        Plaque Psoriasis ABRILADA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are ca
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                                                                                                                                                          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.
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                                                                                                                                                          brand names
                                                                                                                                                          1. ABRILADA
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                                                                                                                                                          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
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                                                                                                                                                          1. ADALIMUMAB-AFZB
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                                                                                                                                                                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) ] .
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                                                                                                                                                                spl effective date
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                                                                                                                                                                regimen
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                                                                                                                                                                tumor histology
                                                                                                                                                                Source null
                                                                                                                                                                use intent
                                                                                                                                                                not_applicable
                                                                                                                                                                Passage 32 · positive indication candidate
                                                                                                                                                                application numbers
                                                                                                                                                                1. BLA761118
                                                                                                                                                                brand names
                                                                                                                                                                1. ABRILADA
                                                                                                                                                                classification reasons
                                                                                                                                                                1. explicit_positive_indication_predicate
                                                                                                                                                                2. no_tumor_directed_keyword_in_positive_statement
                                                                                                                                                                clinical review status
                                                                                                                                                                pending
                                                                                                                                                                content role
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                                                                                                                                                                end
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                                                                                                                                                                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.
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                                                                                                                                                                extraction review status
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                                                                                                                                                                generic names
                                                                                                                                                                1. ADALIMUMAB-AFZB
                                                                                                                                                                id
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                                                                                                                                                                label id
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                                                                                                                                                                qualifier mentions
                                                                                                                                                                1. context exact
                                                                                                                                                                  treatment of moderate to severe hidradenitis suppurativa in adult patients.
                                                                                                                                                                  kind
                                                                                                                                                                  age
                                                                                                                                                                  polarity
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                                                                                                                                                                  adult patients
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                                                                                                                                                                regulatory links
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                                                                                                                                                                    exact text
                                                                                                                                                                    1.8 Hidradenitis Suppurativa ABRILADA is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients.
                                                                                                                                                                    label id
                                                                                                                                                                    fa5fba33-fd55-4011-8871-2c2013b5a0e4
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                                                                                                                                                                    source url
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                                                                                                                                                                    spl effective date
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                                                                                                                                                                    age
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                                                                                                                                                                    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
                                                                                                                                                                    1. BLA761118
                                                                                                                                                                    brand names
                                                                                                                                                                    1. ABRILADA
                                                                                                                                                                    classification reasons
                                                                                                                                                                    1. explicit_positive_indication_predicate
                                                                                                                                                                    2. no_tumor_directed_keyword_in_positive_statement
                                                                                                                                                                    clinical review status
                                                                                                                                                                    pending
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                                                                                                                                                                    context span
                                                                                                                                                                    end
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                                                                                                                                                                    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.
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                                                                                                                                                                    current approval status
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                                                                                                                                                                    duplicate text group
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                                                                                                                                                                    extraction review status
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                                                                                                                                                                    generic names
                                                                                                                                                                    1. ADALIMUMAB-AFZB
                                                                                                                                                                    id
                                                                                                                                                                    ind-span-c03d1f85e496a15e5482
                                                                                                                                                                    label id
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                                                                                                                                                                    positive predicate support span
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                                                                                                                                                                    exact text
                                                                                                                                                                    is indicated
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                                                                                                                                                                    qualifier mentions
                                                                                                                                                                    1. context exact
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                                                                                                                                                                      kind
                                                                                                                                                                      age
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                                                                                                                                                                      adult patients
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                                                                                                                                                                    regulatory links
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                                                                                                                                                                        1.9 Uveitis ABRILADA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.
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                                                                                                                                                                        source url
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                                                                                                                                                                        spl effective date
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                                                                                                                                                                        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