LABELS · 08d15e08-706e-4f2c-af12-bee22e1b8251

Folotyn

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: 2024-09-26
Captured: 2026-09-09T23:37:39.774134+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE FOLOTYN is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on overall response rate [ see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). FOLOTYN is a dihydrofolate reductase inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 )

Full extracted label fields

application numbers

NDA022468

boxed warning exact

brand names

Folotyn

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9f3d9c4d-9386-4451-b712-0fbdc5478d8f

generic names

PRALATREXATE

08d15e08-706e-4f2c-af12-bee22e1b8251

indications and usage exact

1 INDICATIONS AND USAGE FOLOTYN is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on overall response rate [ see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). FOLOTYN is a dihydrofolate reductase inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 )

indications and usage tables exact

is original packager

true

manufacturer names

Acrotech Biopharma Inc

matched search terms

lymphoma

package ndcs

72893-003-01
72893-005-01

product ndcs

72893-003
72893-005

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

INTRAVENOUS

rxcuis

1796419
1796421
1796424
1796425

source batch

file

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

meta

disclaimer

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.

last updated

2026-09-09

license

https://open.fda.gov/license/

results

limit: 100
skip: 0
total: 830

terms

https://open.fda.gov/terms/

sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

url

source url

https://api.fda.gov/drug/label.json?search=id%3A%2208d15e08-706e-4f2c-af12-bee22e1b8251%22

spl effective date

2024-09-26

spl effective time

20240926

spl set id

9f3d9c4d-9386-4451-b712-0fbdc5478d8f

spl version

substance names

PRALATREXATE

uniis

A8Q8I19Q20

verification flags

oncology_keyword_candidate_not_clinically_classified
spl_text_not_verified_identical_to_latest_approved_label
individual_indications_not_split_or_reconciled

Drugs@FDA application source records

application number
NDA022468
payload
all indexed label documents
Appl No
022468
Application Docs Date
2009-09-25 00:00:00
Application Docs ID
17617
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022468lbl.pdf
Submission No
1
Submission Type
ORIG
Appl No
022468
Application Docs Date
2011-01-10 00:00:00
Application Docs ID
17618
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022468s003s004s005lbl.pdf
Submission No
3
Submission Type
SUPPL
Appl No
022468
Application Docs Date
2011-01-10 00:00:00
Application Docs ID
17619
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022468s003s004s005lbl.pdf
Submission No
5
Submission Type
SUPPL
Appl No
022468
Application Docs Date
2012-06-06 00:00:00
Application Docs ID
17620
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022468s010s011lbl.pdf
Submission No
11
Submission Type
SUPPL
Appl No
022468
Application Docs Date
2016-05-17 00:00:00
Application Docs ID
17621
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022468s012lbl.pdf
Submission No
12
Submission Type
SUPPL
Appl No
022468
Application Docs Date
2010-04-28 00:00:00
Application Docs ID
38743
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022468s001lbl.pdf
Submission No
1
Submission Type
SUPPL
Appl No
022468
Application Docs Date
2011-01-10 00:00:00
Application Docs ID
38744
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022468s003s004s005lbl.pdf
Submission No
4
Submission Type
SUPPL
Appl No
022468
Application Docs Date
2012-02-17 00:00:00
Application Docs ID
38745
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022468s009lbl.pdf
Submission No
9
Submission Type
SUPPL
Appl No
022468
Application Docs Date
2012-06-06 00:00:00
Application Docs ID
38746
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022468s010s011lbl.pdf
Submission No
10
Submission Type
SUPPL
Appl No
022468
Application Docs Date
2020-05-19 00:00:00
Application Docs ID
63137
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022468s013lbl.pdf
Submission No
13
Submission Type
SUPPL
Appl No
022468
Application Docs Date
2020-10-23 00:00:00
Application Docs ID
65005
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022468s014lbl.pdf
Submission No
14
Submission Type
SUPPL
all submission records
Appl No
022468
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
11
Submission Status
AP
Submission Status Date
2012-05-30 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
022468
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
12
Submission Status
AP
Submission Status Date
2016-05-13 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
022468
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
13
Submission Status
AP
Submission Status Date
2020-05-14 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
022468
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
14
Submission Status
AP
Submission Status Date
2020-10-20 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
022468
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
10
Submission Status
AP
Submission Status Date
2012-05-30 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
022468
Review Priority
UNKNOWN
Submission Class Code ID
3
Submission No
9
Submission Status
AP
Submission Status Date
2012-02-15 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
022468
Review Priority
UNKNOWN
Submission Class Code ID
3
Submission No
5
Submission Status
AP
Submission Status Date
2011-01-07 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
022468
Review Priority
UNKNOWN
Submission Class Code ID
3
Submission No
4
Submission Status
AP
Submission Status Date
2011-01-07 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
022468
Review Priority
UNKNOWN
Submission Class Code ID
3
Submission No
3
Submission Status
AP
Submission Status Date
2011-01-07 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
022468
Review Priority
UNKNOWN
Submission Class Code ID
3
Submission No
1
Submission Status
AP
Submission Status Date
2010-04-26 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
022468
Review Priority
PRIORITY
Submission Class Code ID
7
Submission No
1
Submission Status
AP
Submission Status Date
2009-09-24 00:00:00
Submission Type
ORIG
Submissions Public Notes
application number
NDA022468
approval interpretation
Application linkage and approved submission are not indication-level current approval verification
current indication status
not_reconciled
drugsfda url
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022468
has approved submission record
true
latest approved submission date
2020-10-20
latest label selection rule
max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
latest posted label documents
Appl No
022468
Application Docs Date
2020-10-23 00:00:00
Application Docs ID
65005
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022468s014lbl.pdf
Submission No
14
Submission Type
SUPPL
official application record
Appl No
022468
Appl Public Notes
Appl Type
NDA
Sponsor Name
ACROTECH BIOPHARMA
openfda application present
true
products
Active Ingredient
PRALATREXATE
Appl No
022468
Drug Name
FOLOTYN
Form
SOLUTION;INTRAVENOUS
Product No
001
Reference Drug
1
Reference Standard
0
Strength
20MG/ML (20MG/ML)
marketing status
Prescription
Active Ingredient
PRALATREXATE
Appl No
022468
Drug Name
FOLOTYN
Form
SOLUTION;INTRAVENOUS
Product No
002
Reference Drug
1
Reference Standard
1
Strength
40MG/2ML (20MG/ML)
marketing status
Prescription

Source passages and status connections

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

Passage 1 · positive indication candidate

application numbers

NDA022468

brand names

Folotyn

classification reasons

explicit_positive_indication_predicate
tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 337
end exclusive: true
exact text: 1 INDICATIONS AND USAGE FOLOTYN is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on overall response rate [ see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and de
label id: 08d15e08-706e-4f2c-af12-bee22e1b8251
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: ffadf6f1a5c3151c3db10c84052fcfe0c1ac479f714d70658b5b858756aabbbf
start: 0

current approval status

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duplicate text group

dup-de11ebb4ead23693bd5e

extraction review status

automated_candidate_pending_source_review

generic names

PRALATREXATE

ind-span-80fa8b6e2098b2d64bc5

label id

08d15e08-706e-4f2c-af12-bee22e1b8251

positive predicate support span

end: 44
end exclusive: true
exact text: is indicated
label id: 08d15e08-706e-4f2c-af12-bee22e1b8251
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: ffadf6f1a5c3151c3db10c84052fcfe0c1ac479f714d70658b5b858756aabbbf
start: 32

qualifier mentions

context exact
AGE FOLOTYN is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
kind
stage_or_setting
polarity
not_inferred
span
end
123
end exclusive
true
exact text
relapsed or refractory peripheral T-cell ly
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08d15e08-706e-4f2c-af12-bee22e1b8251
offset unit
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source array index
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source field
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source text sha256
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start
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regulatory links

schema version

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source batch sha256

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source defined aliases

source span

end: 137
end exclusive: true
exact text: 1 INDICATIONS AND USAGE FOLOTYN is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
label id: 08d15e08-706e-4f2c-af12-bee22e1b8251
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: ffadf6f1a5c3151c3db10c84052fcfe0c1ac479f714d70658b5b858756aabbbf
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%2208d15e08-706e-4f2c-af12-bee22e1b8251%22

spl effective date

2024-09-26

spl set id

9f3d9c4d-9386-4451-b712-0fbdc5478d8f

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

tumor_directed_candidate

Passage 2 · approval contingency

application numbers

NDA022468

brand names

Folotyn

classification reasons

approval_contingency_words

clinical review status

pending

content role

approval_contingency

context span

end: 455
end exclusive: true
exact text: 1 INDICATIONS AND USAGE FOLOTYN is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on overall response rate [ see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). FOLOTYN is a dihydrofolate reductase inhibitor indicated for
label id: 08d15e08-706e-4f2c-af12-bee22e1b8251
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: ffadf6f1a5c3151c3db10c84052fcfe0c1ac479f714d70658b5b858756aabbbf
start: 0

current approval status

not_reconciled

duplicate text group

dup-30a2f4788bad8dde5d58

extraction review status

automated_candidate_pending_source_review

generic names

PRALATREXATE

ind-span-7a3a712b5f4579189c35

label id

08d15e08-706e-4f2c-af12-bee22e1b8251

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

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source batch sha256

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source defined aliases

source span

end: 255
end exclusive: true
exact text: This indication is approved under accelerated approval based on overall response rate [ see Clinical Studies (14) ] .
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offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: ffadf6f1a5c3151c3db10c84052fcfe0c1ac479f714d70658b5b858756aabbbf
start: 138

source url

https://api.fda.gov/drug/label.json?search=id%3A%2208d15e08-706e-4f2c-af12-bee22e1b8251%22

spl effective date

2024-09-26

spl set id

9f3d9c4d-9386-4451-b712-0fbdc5478d8f

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 3 · approval contingency

application numbers

NDA022468

brand names

Folotyn

classification reasons

approval_contingency_words

clinical review status

pending

content role

approval_contingency

context span

end: 594
end exclusive: true
exact text: atment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on overall response rate [ see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). FOLOTYN is a dihydrofolate reductase inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated app
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source array index: 0
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start: 56

current approval status

not_reconciled

duplicate text group

dup-4a13ea2c0a86f5269ec3

extraction review status

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generic names

PRALATREXATE

ind-span-5a76782795c4014439c9

label id

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positive predicate support span

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qualifier mentions

regulatory links

schema version

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source batch sha256

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source defined aliases

source span

end: 394
end exclusive: true
exact text: Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
label id: 08d15e08-706e-4f2c-af12-bee22e1b8251
offset unit: unicode_code_points
source array index: 0
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source text sha256: ffadf6f1a5c3151c3db10c84052fcfe0c1ac479f714d70658b5b858756aabbbf
start: 256

source url

https://api.fda.gov/drug/label.json?search=id%3A%2208d15e08-706e-4f2c-af12-bee22e1b8251%22

spl effective date

2024-09-26

spl set id

9f3d9c4d-9386-4451-b712-0fbdc5478d8f

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 4 · positive indication candidate

application numbers

NDA022468

brand names

Folotyn

classification reasons

explicit_positive_indication_predicate
tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

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content role

positive_indication_candidate

context span

end: 744
end exclusive: true
exact text: sed on overall response rate [ see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). FOLOTYN is a dihydrofolate reductase inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit i
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extraction review status

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positive predicate support span

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exact text: is a dihydrofolate reductase inhibitor indicated
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qualifier mentions

context exact
tase inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
kind
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end
530
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exact text
relapsed or refractory peripheral T-cell ly
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start
487

regulatory links

schema version

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source defined aliases

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end: 544
end exclusive: true
exact text: FOLOTYN is a dihydrofolate reductase inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
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offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: ffadf6f1a5c3151c3db10c84052fcfe0c1ac479f714d70658b5b858756aabbbf
start: 395

source url

https://api.fda.gov/drug/label.json?search=id%3A%2208d15e08-706e-4f2c-af12-bee22e1b8251%22

spl effective date

2024-09-26

spl set id

9f3d9c4d-9386-4451-b712-0fbdc5478d8f

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

tumor_directed_candidate

Passage 5 · approval contingency

application numbers

NDA022468

brand names

Folotyn

classification reasons

approval_contingency_words

clinical review status

pending

content role

approval_contingency

context span

end: 776
end exclusive: true
exact text: n of clinical benefit in a confirmatory trial(s). FOLOTYN is a dihydrofolate reductase inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 )
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offset unit: unicode_code_points
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current approval status

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extraction review status

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PRALATREXATE

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08d15e08-706e-4f2c-af12-bee22e1b8251

positive predicate support span

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qualifier mentions

regulatory links

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exact text: This indication is approved under accelerated approval based on overall response rate.
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source url

https://api.fda.gov/drug/label.json?search=id%3A%2208d15e08-706e-4f2c-af12-bee22e1b8251%22

spl effective date

2024-09-26

spl set id

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structured fields status

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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

not_applicable

Passage 6 · approval contingency

application numbers

NDA022468

brand names

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exact text: inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 )
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positive predicate support span

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qualifier mentions

regulatory links

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source batch sha256

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end: 770
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exact text: Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
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source url

https://api.fda.gov/drug/label.json?search=id%3A%2208d15e08-706e-4f2c-af12-bee22e1b8251%22

spl effective date

2024-09-26

spl set id

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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 7 · unclassified context

application numbers

NDA022468

brand names

Folotyn

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

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end: 776
end exclusive: true
exact text: d under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 )
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08d15e08-706e-4f2c-af12-bee22e1b8251

positive predicate support span

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qualifier mentions

regulatory links

schema version

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source batch sha256

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source defined aliases

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exact text: ( 1 )
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source field: indications_and_usage_exact
source text sha256: ffadf6f1a5c3151c3db10c84052fcfe0c1ac479f714d70658b5b858756aabbbf
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source url

https://api.fda.gov/drug/label.json?search=id%3A%2208d15e08-706e-4f2c-af12-bee22e1b8251%22

spl effective date

2024-09-26

spl set id

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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

Preserved source evidence · Not medical advice