LABELS · 7cedb5f4-cfdd-46a5-836d-e5384c65a224

NEUPOGEN

Open original source → · Download preserved record

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

Label effective date: 2026-07-23
Captured: 2026-09-09T23:37:51.659493+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE NEUPOGEN is a leukocyte growth factor indicated to Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever ( 1.1 ) Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) ( 1.2 ) Reduce the duration of neutropenia and neutropenia-related clinical sequelae, e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT) ( 1.3 ) Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis ( 1.4 ) Reduce the incidence and duration of sequelae of severe neutropenia (e.g., fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia ( 1.5 ) Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) ( 1.6 ) 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy NEUPOGEN is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever [see Clinical Studies (14.1) ] . 1.2 Patients with Acute Myeloid Leukemia Receiving Induction or Consolidation Chemotherapy NEUPOGEN is indicated for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) [see Clinical Studies (14.2) ] . 1.3 Patients with Cancer Undergoing Bone Marrow Transplantation NEUPOGEN is indicated to reduce the duration of neutropenia and neutropenia-related clinical sequelae, e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation [see Clinical Studies (14.3) ] . 1.4 Patients Undergoing Autologous Peripheral Blood Progenitor Cell Collection and Therapy NEUPOGEN is indicated for the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis [see Clinical Studies (14.4) ] . 1.5 Patients with Severe Chronic Neutropenia NEUPOGEN is indicated for chronic administration to reduce the incidence and duration of sequelae of neutropenia (e.g., fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia [see Clinical Studies (14.5) ] . 1.6 Patients Acutely Exposed to Myelosuppressive Doses of Radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) NEUPOGEN is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation [see Clinical Studies (14.6) ] .

Full extracted label fields

application numbers

BLA103353

boxed warning exact

brand names

NEUPOGEN

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=97cc73cc-b5b7-458a-a933-77b00523e193

generic names

FILGRASTIM

7cedb5f4-cfdd-46a5-836d-e5384c65a224

indications and usage exact

1 INDICATIONS AND USAGE NEUPOGEN is a leukocyte growth factor indicated to Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever ( 1.1 ) Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) ( 1.2 ) Reduce the duration of neutropenia and neutropenia-related clinical sequelae, e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT) ( 1.3 ) Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis ( 1.4 ) Reduce the incidence and duration of sequelae of severe neutropenia (e.g., fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia ( 1.5 ) Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) ( 1.6 ) 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy NEUPOGEN is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever [see Clinical Studies (14.1) ] . 1.2 Patients with Acute Myeloid Leukemia Receiving Induction or Consolidation Chemotherapy NEUPOGEN is indicated for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) [see Clinical Studies (14.2) ] . 1.3 Patients with Cancer Undergoing Bone Marrow Transplantation NEUPOGEN is indicated to reduce the duration of neutropenia and neutropenia-related clinical sequelae, e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation [see Clinical Studies (14.3) ] . 1.4 Patients Undergoing Autologous Peripheral Blood Progenitor Cell Collection and Therapy NEUPOGEN is indicated for the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis [see Clinical Studies (14.4) ] . 1.5 Patients with Severe Chronic Neutropenia NEUPOGEN is indicated for chronic administration to reduce the incidence and duration of sequelae of neutropenia (e.g., fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia [see Clinical Studies (14.5) ] . 1.6 Patients Acutely Exposed to Myelosuppressive Doses of Radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) NEUPOGEN is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation [see Clinical Studies (14.6) ] .

indications and usage tables exact

is original packager

true

manufacturer names

Amgen, Inc

matched search terms

cancer
leukemia

package ndcs

55513-530-01
55513-530-10
55513-530-20
55513-546-01
55513-546-10
55513-546-20
55513-924-01
55513-924-10
55513-924-91
55513-924-20
55513-209-01
55513-209-10

product ndcs

55513-209
55513-530
55513-546
55513-924

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

Warnings and Precautions, Large and Medium Vessel Arteritis ( 5.15 ) 07/2026

record type

complete_spl_indications_section_candidate

routes

INTRAVENOUS
SUBCUTANEOUS

rxcuis

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1649946
1649963
1649964

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

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url

source url

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spl effective date

2026-07-23

spl effective time

20260723

spl set id

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spl version

166

substance names

FILGRASTIM

uniis

PVI5M0M1GW

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spl_text_not_verified_identical_to_latest_approved_label
individual_indications_not_split_or_reconciled

Drugs@FDA application source records

application number
BLA103353
payload
all indexed label documents
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103353
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18574
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5127
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SUPPL
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103353
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2013-09-17 00:00:00
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18575
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0
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2
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5157
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SUPPL
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103353
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2015-02-06 00:00:00
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18576
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0
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103353
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18577
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39647
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2
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5001
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103353
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2012-05-29 00:00:00
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39648
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0
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2
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5147
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SUPPL
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103353
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2016-07-22 00:00:00
Application Docs ID
39649
Application Docs Title
0
Application Docs Type ID
2
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103353s5188.pdf
Submission No
5188
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SUPPL
Appl No
103353
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2017-04-25 00:00:00
Application Docs ID
48095
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0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103353s5183lbl.pdf
Submission No
5183
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SUPPL
Appl No
103353
Application Docs Date
2018-06-26 00:00:00
Application Docs ID
54686
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0
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2
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http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103353s5194lbl.pdf
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5194
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SUPPL
all submission records
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103353
Review Priority
PRIORITY
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7
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1
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AP
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1991-02-20 00:00:00
Submission Type
ORIG
Submissions Public Notes
Appl No
103353
Review Priority
PRIORITY
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1007
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AP
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Appl No
103353
Review Priority
UNKNOWN
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2
Submission No
1009
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AP
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1994-06-15 00:00:00
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SUPPL
Submissions Public Notes
Appl No
103353
Review Priority
UNKNOWN
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2
Submission No
1027
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AP
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1995-12-28 00:00:00
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SUPPL
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Appl No
103353
Review Priority
UNKNOWN
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2
Submission No
1036
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AP
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1998-04-02 00:00:00
Submission Type
SUPPL
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Appl No
103353
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
1051
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AP
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2001-06-21 00:00:00
Submission Type
SUPPL
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Appl No
103353
Review Priority
STANDARD
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3
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5001
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AP
Submission Status Date
2002-05-29 00:00:00
Submission Type
SUPPL
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Appl No
103353
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
5058
Submission Status
AP
Submission Status Date
2004-11-24 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
103353
Review Priority
STANDARD
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3
Submission No
5059
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AP
Submission Status Date
2004-12-17 00:00:00
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SUPPL
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Appl No
103353
Review Priority
Submission Class Code ID
6
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5086
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AP
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2006-10-25 00:00:00
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SUPPL
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103353
Review Priority
STANDARD
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3
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AP
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2007-09-27 00:00:00
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Appl No
103353
Review Priority
STANDARD
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3
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5127
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AP
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2010-03-02 00:00:00
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application number
BLA103353
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=103353
has approved submission record
true
latest approved submission date
2026-07-16
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
103353
Application Docs Date
2026-07-21 00:00:00
Application Docs ID
86623
Application Docs Title
0
Application Docs Type ID
2
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https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/103353s5202lbl.pdf
Submission No
5202
Submission Type
SUPPL
official application record
Appl No
103353
Appl Public Notes
Appl Type
BLA
Sponsor Name
AMGEN
openfda application present
true
products
Active Ingredient
FILGRASTIM
Appl No
103353
Drug Name
NEUPOGEN
Form
VIAL
Product No
001
Reference Drug
0
Reference Standard
Strength
300MCG/1ML
marketing status
Prescription
Active Ingredient
FILGRASTIM
Appl No
103353
Drug Name
NEUPOGEN
Form
VIAL
Product No
002
Reference Drug
0
Reference Standard
Strength
480MCG/1.6ML
marketing status
Prescription
Active Ingredient
FILGRASTIM
Appl No
103353
Drug Name
NEUPOGEN
Form
SYRINGE
Product No
003
Reference Drug
0
Reference Standard
Strength
300MGC/0.5ML
marketing status
Prescription
Active Ingredient
FILGRASTIM
Appl No
103353
Drug Name
NEUPOGEN
Form
SYRINGE
Product No
004
Reference Drug
0
Reference Standard
Strength
480MCG/0.8ML
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

BLA103353

brand names

NEUPOGEN

classification reasons

explicit_positive_indication_predicate
supportive_or_complication_use_words

clinical review status

pending

content role

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exact text: 1 INDICATIONS AND USAGE NEUPOGEN is a leukocyte growth factor indicated to Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever ( 1.1 ) Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) ( 1.2 ) Reduce the duration of neutropenia and neutropenia-related clinical sequelae, e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT) ( 1.3 ) Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis ( 1.4 ) Reduce the incidence and duration of sequelae of severe neutropenia (e.g., fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia ( 1.5 ) Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) ( 1.6 ) 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy NEUPOGEN is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malign
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exact text: 1 INDICATIONS AND USAGE NEUPOGEN is a leukocyte growth factor indicated to Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever ( 1.1 ) Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) ( 1.2 ) Reduce the duration of neutropenia and neutropenia-related clinical sequelae, e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT) ( 1.3 ) Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis ( 1.4 ) Reduce the incidence and duration of sequelae of severe neutropenia (e.g., fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia ( 1.5 ) Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) ( 1.6 )
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spl effective date

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structured indication

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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

Passage 2 · positive indication candidate

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exact text: cyclic neutropenia, or idiopathic neutropenia ( 1.5 ) Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) ( 1.6 ) 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy NEUPOGEN is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever [see Clinical Studies (14.1) ] . 1.2 Patients with Acute Myeloid Leukemia Receiving Induction or Consolidation Chemotherapy NEUPOGEN is indicated for reducing the time to neutrophil recovery and the duration of fever, following indu
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exact text: 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy NEUPOGEN is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever [see Clinical Studies (14.1) ] .
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source url

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spl effective date

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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

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Passage 3 · positive indication candidate

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NEUPOGEN

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Preserved source evidence · Not medical advice