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LABELS · a090f981-1f1f-4a5b-adc7-31f1022c4748

Neulasta

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
2026-08-10
Captured
2026-09-09T23:37:54.830918+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Neulasta is a leukocyte growth factor indicated in adult and pediatric patients 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 Neulasta is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy Neulasta is indicated in adult and pediatric patients 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 Neulasta 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 Neulasta is indicated to increase survival in adults and pediatric 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
  1. BLA125031
boxed warning exact
    brand names
    1. Neulasta
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce
    generic names
    1. PEGFILGRASTIM
    id
    a090f981-1f1f-4a5b-adc7-31f1022c4748
    indications and usage exact
    1. 1 INDICATIONS AND USAGE Neulasta is a leukocyte growth factor indicated in adult and pediatric patients 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 Neulasta is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy Neulasta is indicated in adult and pediatric patients 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 Neulasta 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 Neulasta is indicated to increase survival in adults and pediatric 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
      1. true
      manufacturer names
      1. Amgen, Inc
      matched search terms
      1. cancer
      package ndcs
      1. 55513-192-01
      2. 55513-190-01
      3. 55513-099-01
      product ndcs
      1. 55513-099
      2. 55513-192
      3. 55513-190
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Dosage and Administration ( 2 ) 08/2025 Warnings and Precautions, Large and Medium Vessel Arteritis ( 5.13 ) 08/2026
      record type
      complete_spl_indications_section_candidate
      routes
      1. SUBCUTANEOUS
      rxcuis
      1. 727539
      2. 727542
      3. 2549331
      4. 2549333
      5. 2739503
      6. 2739504
      source batch
      file
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      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
      results
      limit
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      skip
      500
      total
      830
      sha256
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      url
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      source url
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      spl effective date
      2026-08-10
      spl effective time
      20260810
      spl set id
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      spl version
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      substance names
      1. PEGFILGRASTIM
      uniis
      1. 3A58010674
      verification flags
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      2. spl_text_not_verified_identical_to_latest_approved_label
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      4. fda_label_posted_after_spl_effective_date_requires_version_review
      Drugs@FDA application source records
      1. application number
        BLA125031
        payload
        all indexed label documents
        1. Appl No
          125031
          Application Docs Date
          2004-03-25 00:00:00
          Application Docs ID
          18736
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
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          Application Docs Date
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          Application Docs ID
          18737
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          52
          Submission Type
          SUPPL
        3. Appl No
          125031
          Application Docs Date
          2007-08-02 00:00:00
          Application Docs ID
          18738
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          82
          Submission Type
          SUPPL
        4. Appl No
          125031
          Application Docs Date
          2015-10-06 00:00:00
          Application Docs ID
          18739
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          179
          Submission Type
          SUPPL
        5. Appl No
          125031
          Application Docs Date
          2005-01-26 00:00:00
          Application Docs ID
          39787
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          48
          Submission Type
          SUPPL
        6. Appl No
          125031
          Application Docs Date
          2005-01-26 00:00:00
          Application Docs ID
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          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          51
          Submission Type
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        7. Appl No
          125031
          Application Docs Date
          2006-11-09 00:00:00
          Application Docs ID
          39789
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          72
          Submission Type
          SUPPL
        8. Appl No
          125031
          Application Docs Date
          2012-05-29 00:00:00
          Application Docs ID
          39790
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          142
          Submission Type
          SUPPL
        9. Appl No
          125031
          Application Docs Date
          2015-10-06 00:00:00
          Application Docs ID
          39791
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          170
          Submission Type
          SUPPL
        10. Appl No
          125031
          Application Docs Date
          2015-11-19 00:00:00
          Application Docs ID
          39792
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          180
          Submission Type
          SUPPL
        11. Appl No
          125031
          Application Docs Date
          2015-10-06 00:00:00
          Application Docs ID
          39793
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          181
          Submission Type
          SUPPL
        12. Appl No
          125031
          Application Docs Date
          2016-04-29 00:00:00
          Application Docs ID
          39794
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          184
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          125031
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          210
          Submission Status
          AP
          Submission Status Date
          2026-08-04 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        2. Appl No
          125031
          Review Priority
          N/A
          Submission Class Code ID
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          Submission No
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          Submission Status
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          Submission Status Date
          2025-08-18 00:00:00
          Submission Type
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          Submissions Public Notes
        3. Appl No
          125031
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
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          Submission Status
          AP
          Submission Status Date
          2021-02-02 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          125031
          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
          202
          Submission Status
          AP
          Submission Status Date
          2021-01-05 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          125031
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          201
          Submission Status
          AP
          Submission Status Date
          2020-11-18 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          125031
          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
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          AP
          Submission Status Date
          2020-01-06 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          125031
          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
          198
          Submission Status
          AP
          Submission Status Date
          2019-04-16 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          125031
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          193
          Submission Status
          AP
          Submission Status Date
          2018-06-18 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          125031
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          191
          Submission Status
          AP
          Submission Status Date
          2017-12-09 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        10. Appl No
          125031
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          189
          Submission Status
          AP
          Submission Status Date
          2017-12-09 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        11. Appl No
          125031
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          184
          Submission Status
          AP
          Submission Status Date
          2016-04-28 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        12. Appl No
          125031
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          181
          Submission Status
          AP
          Submission Status Date
          2015-09-23 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        BLA125031
        approval interpretation
        Application linkage and approved submission are not indication-level current approval verification
        current indication status
        not_reconciled
        has approved submission record
        true
        latest approved submission date
        2026-08-04
        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
        1. Appl No
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          Application Docs Date
          2026-08-11 00:00:00
          Application Docs ID
          86841
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          210
          Submission Type
          SUPPL
        official application record
        Appl No
        125031
        Appl Public Notes
        Appl Type
        BLA
        Sponsor Name
        AMGEN
        openfda application present
        true
        products
        1. Active Ingredient
          PEGFILGRASTIM
          Appl No
          125031
          Drug Name
          NEULASTA
          Form
          SYRINGE
          Product No
          001
          Reference Drug
          0
          Reference Standard
          Strength
          6MG/0.6ML
          marketing status
          1. 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
      1. BLA125031
      brand names
      1. Neulasta
      classification reasons
      1. explicit_positive_indication_predicate
      2. supportive_or_complication_use_words
      clinical review status
      pending
      content role
      positive_indication_candidate
      context span
      end
      543
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE Neulasta is a leukocyte growth factor indicated in adult and pediatric patients 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 Neulasta is not indica
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      duplicate text group
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      is a leukocyte growth factor indicated
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      qualifier mentions
      1. context exact
        ND USAGE Neulasta is a leukocyte growth factor indicated in adult and pediatric patients to Decrease the incidence of infecti
        kind
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        polarity
        not_inferred
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        end exclusive
        true
        exact text
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      2. context exact
        eulasta is a leukocyte growth factor indicated in adult and pediatric patients to Decrease the incidence of infection, as manifested by fe
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        source defined aliases
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          1 INDICATIONS AND USAGE Neulasta is a leukocyte growth factor indicated in adult and pediatric patients 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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          biomarker and test
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          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 Neulasta is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosup
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                ( 1.1 ) Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).
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                Source null
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                Passage 3 · limitation of use
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                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 Neulasta is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy Neulasta is indicated in adult and pediatric patients to decrease the incidence of infection, as manifested by febrile neutropenia, in
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                positive predicate support span
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