LABELS · 4c6e7e6f-aadd-45b1-baed-970b24766bf3

FIRMAGON

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: 2024-01-30
Captured: 2026-09-09T23:37:47.659725+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE FIRMAGON ® is indicated for treatment of patients with advanced prostate cancer. FIRMAGON is a GnRH receptor antagonist indicated for treatment of patients with advanced prostate cancer. ( 1 )

Full extracted label fields

application numbers

NDA022201

boxed warning exact

brand names

FIRMAGON

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ab11dd8a-0fd9-4013-89ab-e114557c7e4b

generic names

DEGARELIX

4c6e7e6f-aadd-45b1-baed-970b24766bf3

indications and usage exact

1 INDICATIONS AND USAGE FIRMAGON ® is indicated for treatment of patients with advanced prostate cancer. FIRMAGON is a GnRH receptor antagonist indicated for treatment of patients with advanced prostate cancer. ( 1 )

indications and usage tables exact

is original packager

true

manufacturer names

Ferring Pharmaceuticals Inc.

matched search terms

cancer

package ndcs

55566-8403-1
55566-8303-1

product ndcs

55566-8303
55566-8403

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

Warnings and Precautions, Embryo-Fetal Toxicity ( 5.4 ) 02/2020

record type

complete_spl_indications_section_candidate

routes

rxcuis

828749
828751
858125
858127

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00300.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: 300
total: 830

terms

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

sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

url

source url

https://api.fda.gov/drug/label.json?search=id%3A%224c6e7e6f-aadd-45b1-baed-970b24766bf3%22

spl effective date

2024-01-30

spl effective time

20240130

spl set id

ab11dd8a-0fd9-4013-89ab-e114557c7e4b

spl version

substance names

uniis

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
NDA022201
payload
all indexed label documents
Appl No
022201
Application Docs Date
2008-12-29 00:00:00
Application Docs ID
17076
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022201lbl.pdf
Submission No
1
Submission Type
ORIG
Appl No
022201
Application Docs Date
2013-03-08 00:00:00
Application Docs ID
17077
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022201s002lbl.pdf
Submission No
2
Submission Type
SUPPL
Appl No
022201
Application Docs Date
2015-03-03 00:00:00
Application Docs ID
17078
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022201s009lbl.pdf
Submission No
9
Submission Type
SUPPL
Appl No
022201
Application Docs Date
2013-08-21 00:00:00
Application Docs ID
38375
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022201s003lbl.pdf
Submission No
3
Submission Type
SUPPL
Appl No
022201
Application Docs Date
2015-11-04 00:00:00
Application Docs ID
38376
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022201s011lbl.pdf
Submission No
11
Submission Type
SUPPL
Appl No
022201
Application Docs Date
2020-02-25 00:00:00
Application Docs ID
61959
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022201s016lbl.pdf
Submission No
16
Submission Type
SUPPL
all submission records
Appl No
022201
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
16
Submission Status
AP
Submission Status Date
2020-02-24 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
022201
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
13
Submission Status
AP
Submission Status Date
2016-06-21 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
022201
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
12
Submission Status
AP
Submission Status Date
2016-01-12 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
022201
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
11
Submission Status
AP
Submission Status Date
2015-10-27 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
022201
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
10
Submission Status
AP
Submission Status Date
2015-07-31 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
022201
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
9
Submission Status
AP
Submission Status Date
2015-02-26 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
022201
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
8
Submission Status
AP
Submission Status Date
2014-12-15 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
022201
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
6
Submission Status
AP
Submission Status Date
2014-11-10 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
022201
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
5
Submission Status
AP
Submission Status Date
2014-09-26 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
022201
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
4
Submission Status
AP
Submission Status Date
2014-03-25 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
022201
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
3
Submission Status
AP
Submission Status Date
2013-08-16 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
022201
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
2
Submission Status
AP
Submission Status Date
2013-03-05 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA022201
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=022201
has approved submission record
true
latest approved submission date
2020-02-24
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
022201
Application Docs Date
2020-02-25 00:00:00
Application Docs ID
61959
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022201s016lbl.pdf
Submission No
16
Submission Type
SUPPL
official application record
Appl No
022201
Appl Public Notes
Appl Type
NDA
Sponsor Name
FERRING
openfda application present
true
products
Active Ingredient
DEGARELIX ACETATE
Appl No
022201
Drug Name
FIRMAGON
Form
POWDER;SUBCUTANEOUS
Product No
001
Reference Drug
1
Reference Standard
0
Strength
EQ 80MG BASE/VIAL
marketing status
Prescription
Active Ingredient
DEGARELIX ACETATE
Appl No
022201
Drug Name
FIRMAGON
Form
POWDER;SUBCUTANEOUS
Product No
002
Reference Drug
1
Reference Standard
1
Strength
EQ 120MG BASE/VIAL
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

NDA022201

brand names

FIRMAGON

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: 216
end exclusive: true
exact text: 1 INDICATIONS AND USAGE FIRMAGON ® is indicated for treatment of patients with advanced prostate cancer. FIRMAGON is a GnRH receptor antagonist indicated for treatment of patients with advanced prostate cancer. ( 1 )
label id: 4c6e7e6f-aadd-45b1-baed-970b24766bf3
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: e49ee42e0115c0408a5df411bd9ccfc659101704bde1c9945bd536d6f737a789
start: 0

current approval status

not_reconciled

duplicate text group

dup-47fc6268db29a011d4bf

extraction review status

automated_candidate_pending_source_review

generic names

DEGARELIX

ind-span-8bd5a1a15c85702a0a19

label id

4c6e7e6f-aadd-45b1-baed-970b24766bf3

positive predicate support span

end: 47
end exclusive: true
exact text: is indicated
label id: 4c6e7e6f-aadd-45b1-baed-970b24766bf3
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: e49ee42e0115c0408a5df411bd9ccfc659101704bde1c9945bd536d6f737a789
start: 35

qualifier mentions

context exact
SAGE FIRMAGON ® is indicated for treatment of patients with advanced prostate cancer.
kind
stage_or_setting
polarity
not_inferred
span
end
103
end exclusive
true
exact text
advanced prostate cancer
label id
4c6e7e6f-aadd-45b1-baed-970b24766bf3
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
e49ee42e0115c0408a5df411bd9ccfc659101704bde1c9945bd536d6f737a789
start
79

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 104
end exclusive: true
exact text: 1 INDICATIONS AND USAGE FIRMAGON ® is indicated for treatment of patients with advanced prostate cancer.
label id: 4c6e7e6f-aadd-45b1-baed-970b24766bf3
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: e49ee42e0115c0408a5df411bd9ccfc659101704bde1c9945bd536d6f737a789
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%224c6e7e6f-aadd-45b1-baed-970b24766bf3%22

spl effective date

2024-01-30

spl set id

ab11dd8a-0fd9-4013-89ab-e114557c7e4b

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 · positive indication candidate

application numbers

NDA022201

brand names

FIRMAGON

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: 216
end exclusive: true
exact text: 1 INDICATIONS AND USAGE FIRMAGON ® is indicated for treatment of patients with advanced prostate cancer. FIRMAGON is a GnRH receptor antagonist indicated for treatment of patients with advanced prostate cancer. ( 1 )
label id: 4c6e7e6f-aadd-45b1-baed-970b24766bf3
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: e49ee42e0115c0408a5df411bd9ccfc659101704bde1c9945bd536d6f737a789
start: 0

current approval status

not_reconciled

duplicate text group

dup-686f364ff2b6894dad22

extraction review status

automated_candidate_pending_source_review

generic names

DEGARELIX

ind-span-c95c61c463b03454df1c

label id

4c6e7e6f-aadd-45b1-baed-970b24766bf3

positive predicate support span

end: 153
end exclusive: true
exact text: is a GnRH receptor antagonist indicated
label id: 4c6e7e6f-aadd-45b1-baed-970b24766bf3
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: e49ee42e0115c0408a5df411bd9ccfc659101704bde1c9945bd536d6f737a789
start: 114

qualifier mentions

context exact
eceptor antagonist indicated for treatment of patients with advanced prostate cancer.
kind
stage_or_setting
polarity
not_inferred
span
end
209
end exclusive
true
exact text
advanced prostate cancer
label id
4c6e7e6f-aadd-45b1-baed-970b24766bf3
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
e49ee42e0115c0408a5df411bd9ccfc659101704bde1c9945bd536d6f737a789
start
185

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 210
end exclusive: true
exact text: FIRMAGON is a GnRH receptor antagonist indicated for treatment of patients with advanced prostate cancer.
label id: 4c6e7e6f-aadd-45b1-baed-970b24766bf3
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: e49ee42e0115c0408a5df411bd9ccfc659101704bde1c9945bd536d6f737a789
start: 105

source url

https://api.fda.gov/drug/label.json?search=id%3A%224c6e7e6f-aadd-45b1-baed-970b24766bf3%22

spl effective date

2024-01-30

spl set id

ab11dd8a-0fd9-4013-89ab-e114557c7e4b

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 3 · unclassified context

application numbers

NDA022201

brand names

FIRMAGON

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 216
end exclusive: true
exact text: NS AND USAGE FIRMAGON ® is indicated for treatment of patients with advanced prostate cancer. FIRMAGON is a GnRH receptor antagonist indicated for treatment of patients with advanced prostate cancer. ( 1 )
label id: 4c6e7e6f-aadd-45b1-baed-970b24766bf3
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: e49ee42e0115c0408a5df411bd9ccfc659101704bde1c9945bd536d6f737a789
start: 11

current approval status

not_reconciled

duplicate text group

dup-ef7a3b302e22c8249248

extraction review status

automated_candidate_pending_source_review

generic names

DEGARELIX

ind-span-b0230535c95824f000fd

label id

4c6e7e6f-aadd-45b1-baed-970b24766bf3

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 216
end exclusive: true
exact text: ( 1 )
label id: 4c6e7e6f-aadd-45b1-baed-970b24766bf3
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: e49ee42e0115c0408a5df411bd9ccfc659101704bde1c9945bd536d6f737a789
start: 211

source url

https://api.fda.gov/drug/label.json?search=id%3A%224c6e7e6f-aadd-45b1-baed-970b24766bf3%22

spl effective date

2024-01-30

spl set id

ab11dd8a-0fd9-4013-89ab-e114557c7e4b

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