LABELS · 7a30003f-a148-4c35-bf21-b4822e970eb5

UDENYCA

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: 2025-08-14
Captured: 2026-09-09T23:37:51.659493+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE UDENYCA is a leukocyte growth factor indicated to Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. ( 1.1 ) Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). ( 1.2 ) Limitations of Use UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy UDENYCA is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia [see Clinical Studies ( 14.1 )] . Limitations of Use UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.2 Patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome UDENYCA is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation [see Dosage and Administration ( 2.2 ) and Clinical Studies ( 14.2 )] .

Full extracted label fields

application numbers

BLA761039

boxed warning exact

brand names

UDENYCA

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a8c290ee-b699-4395-a596-1453d4a4b4eb

generic names

PEGFILGRASTIM-CBQV

7a30003f-a148-4c35-bf21-b4822e970eb5

indications and usage exact

1 INDICATIONS AND USAGE UDENYCA is a leukocyte growth factor indicated to Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. ( 1.1 ) Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). ( 1.2 ) Limitations of Use UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy UDENYCA is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia [see Clinical Studies ( 14.1 )] . Limitations of Use UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.2 Patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome UDENYCA is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation [see Dosage and Administration ( 2.2 ) and Clinical Studies ( 14.2 )] .

indications and usage tables exact

is original packager

true

manufacturer names

Coherus Oncology, Inc.

matched search terms

cancer

package ndcs

70114-101-01
70114-120-01
70114-130-01

product ndcs

70114-101
70114-120
70114-130

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

Dosage and Administration ( 2.2 ) and ( 2.3 ) 12/2023

record type

complete_spl_indications_section_candidate

routes

SUBCUTANEOUS

rxcuis

2102703
2102705
2632544
2632547
2673598
2673602

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00400.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: 400
total: 830

terms

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

sha256

a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef

url

source url

https://api.fda.gov/drug/label.json?search=id%3A%227a30003f-a148-4c35-bf21-b4822e970eb5%22

spl effective date

2025-08-14

spl effective time

20250814

spl set id

a8c290ee-b699-4395-a596-1453d4a4b4eb

spl version

substance names

PEGFILGRASTIM

uniis

3A58010674

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
BLA761039
payload
all indexed label documents
Appl No
761039
Application Docs Date
2018-11-02 00:00:00
Application Docs ID
56250
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761039s000lbl.pdf
Submission No
1
Submission Type
ORIG
Appl No
761039
Application Docs Date
2020-01-28 00:00:00
Application Docs ID
60593
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761039s001lbl.pdf
Submission No
1
Submission Type
SUPPL
Appl No
761039
Application Docs Date
2020-02-13 00:00:00
Application Docs ID
61877
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761039s003lbl.pdf
Submission No
3
Submission Type
SUPPL
Appl No
761039
Application Docs Date
2021-06-08 00:00:00
Application Docs ID
67742
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761039s010lbl.pdf
Submission No
10
Submission Type
SUPPL
Appl No
761039
Application Docs Date
2022-11-29 00:00:00
Application Docs ID
72749
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761039s014lbl.pdf
Submission No
14
Submission Type
SUPPL
Appl No
761039
Application Docs Date
2023-03-06 00:00:00
Application Docs ID
73676
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761039s013lbl.pdf
Submission No
13
Submission Type
SUPPL
Appl No
761039
Application Docs Date
2023-12-22 00:00:00
Application Docs ID
77126
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761039Orig1s015lbl.pdf
Submission No
15
Submission Type
SUPPL
all submission records
Appl No
761039
Review Priority
STANDARD
Submission Class Code ID
2
Submission No
15
Submission Status
AP
Submission Status Date
2023-12-22 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
761039
Review Priority
STANDARD
Submission Class Code ID
2
Submission No
14
Submission Status
AP
Submission Status Date
2022-11-28 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
761039
Review Priority
STANDARD
Submission Class Code ID
2
Submission No
13
Submission Status
AP
Submission Status Date
2023-03-03 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
761039
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
10
Submission Status
AP
Submission Status Date
2021-06-07 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
761039
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
4
Submission Status
AP
Submission Status Date
2019-10-17 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
761039
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
3
Submission Status
AP
Submission Status Date
2020-02-12 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
761039
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
1
Submission Status
AP
Submission Status Date
2019-04-16 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
761039
Review Priority
STANDARD
Submission Class Code ID
15
Submission No
1
Submission Status
AP
Submission Status Date
2018-11-02 00:00:00
Submission Type
ORIG
Submissions Public Notes
application number
BLA761039
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=761039
has approved submission record
true
latest approved submission date
2023-12-22
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
761039
Application Docs Date
2023-12-22 00:00:00
Application Docs ID
77126
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761039Orig1s015lbl.pdf
Submission No
15
Submission Type
SUPPL
official application record
Appl No
761039
Appl Public Notes
Appl Type
BLA
Sponsor Name
COHERUS BIOSCIENCES INC
openfda application present
true
products
Active Ingredient
PEGFILGRASTIM-CBQV
Appl No
761039
Drug Name
UDENYCA
Form
INJECTABLE;INJECTION
Product No
001
Reference Drug
0
Reference Standard
0
Strength
6MG/0.6ML
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

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UDENYCA

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exact text: 1 INDICATIONS AND USAGE UDENYCA is a leukocyte growth factor indicated to Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. ( 1.1 ) Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). ( 1.2 ) Limitations of Use UDENYCA is not indicat
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exact text: 1 INDICATIONS AND USAGE UDENYCA is a leukocyte growth factor indicated to Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
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source url

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spl effective date

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structured indication

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use intent

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Passage 2 · unclassified context

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UDENYCA

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exact text: as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. ( 1.1 ) Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). ( 1.2 ) Limitations of Use UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosupp
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source url

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spl effective date

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structured indication

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tumor histology: Source null

use intent

unclear

Passage 3 · limitation of use

application numbers

BLA761039

brand names

UDENYCA

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clinical review status

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exact text: lly significant incidence of febrile neutropenia. ( 1.1 ) Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). ( 1.2 ) Limitations of Use UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy UDENYCA is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malign
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UDENYCA

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exact text: ic Subsyndrome of Acute Radiation Syndrome). ( 1.2 ) Limitations of Use UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy UDENYCA is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia [see Clinical Studies ( 14.1 )] . Limitations of Use UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.2 Patients with Hematopoietic Subsyndrome of Acute
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Passage 5 · limitation of use

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exact text: nia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia [see Clinical Studies ( 14.1 )] . Limitations of Use UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.2 Patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome UDENYCA is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation [see Dosage and Ad
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tumor histology: Source null

use intent

not_applicable

Passage 6 · positive indication candidate

application numbers

BLA761039

brand names

UDENYCA

classification reasons

explicit_positive_indication_predicate
supportive_or_complication_use_words

clinical review status

pending

content role

positive_indication_candidate

context span

end: 1374
end exclusive: true
exact text: ebrile neutropenia [see Clinical Studies ( 14.1 )] . Limitations of Use UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.2 Patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome UDENYCA is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation [see Dosage and Administration ( 2.2 ) and Clinical Studies ( 14.2 )] .
label id: 7a30003f-a148-4c35-bf21-b4822e970eb5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 35b8237381ec8da2f670d3f7969c874dcde28c5214311e8d3620d571097f74f1
start: 922

current approval status

not_reconciled

duplicate text group

dup-b92250f416955c4aa523

extraction review status

automated_candidate_pending_source_review

generic names

PEGFILGRASTIM-CBQV

ind-span-984baed8794444680c3d

label id

7a30003f-a148-4c35-bf21-b4822e970eb5

positive predicate support span

end: 1214
end exclusive: true
exact text: is indicated
label id: 7a30003f-a148-4c35-bf21-b4822e970eb5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 35b8237381ec8da2f670d3f7969c874dcde28c5214311e8d3620d571097f74f1
start: 1202

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef

source defined aliases

source span

end: 1374
end exclusive: true
exact text: 1.2 Patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome UDENYCA is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation [see Dosage and Administration ( 2.2 ) and Clinical Studies ( 14.2 )] .
label id: 7a30003f-a148-4c35-bf21-b4822e970eb5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 35b8237381ec8da2f670d3f7969c874dcde28c5214311e8d3620d571097f74f1
start: 1122

source url

https://api.fda.gov/drug/label.json?search=id%3A%227a30003f-a148-4c35-bf21-b4822e970eb5%22

spl effective date

2025-08-14

spl set id

a8c290ee-b699-4395-a596-1453d4a4b4eb

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

supportive_care_candidate

Preserved source evidence · Not medical advice