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LABELS · e562b389-581e-4cf2-a09d-0bd6093d9027

NYVEPRIA

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
2026-06-02
Captured
2026-09-09T23:38:02.384588+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Patients with Cancer Receiving Myelosuppressive Chemotherapy NYVEPRIA is indicated in adults and pediatric patients aged newborn and older 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 Dosage and Administration (2.1) and Clinical Studies (14) ] . NYVEPRIA is a leukocyte growth factor indicated in adults and pediatric patients aged newborn and older 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 ) Limitations of Use NYVEPRIA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. ( 1 ) Limitations of Use NYVEPRIA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
Full extracted label fields
application numbers
  1. BLA761111
boxed warning exact
    brand names
    1. NYVEPRIA
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=99d30b99-2743-446b-98f3-0430bf4ea869
    generic names
    1. PEGFILGRASTIM-APGF
    id
    e562b389-581e-4cf2-a09d-0bd6093d9027
    indications and usage exact
    1. 1 INDICATIONS AND USAGE Patients with Cancer Receiving Myelosuppressive Chemotherapy NYVEPRIA is indicated in adults and pediatric patients aged newborn and older 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 Dosage and Administration (2.1) and Clinical Studies (14) ] . NYVEPRIA is a leukocyte growth factor indicated in adults and pediatric patients aged newborn and older 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 ) Limitations of Use NYVEPRIA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. ( 1 ) Limitations of Use NYVEPRIA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Pfizer Laboratories Div Pfizer Inc
      matched search terms
      1. cancer
      package ndcs
      1. 0069-0324-01
      product ndcs
      1. 0069-0324
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. SUBCUTANEOUS
        rxcuis
        1. 2469335
        2. 2469340
        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
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        total
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        sha256
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        url
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        source url
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        spl effective date
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        spl effective time
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        spl set id
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        spl version
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        substance names
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        uniis
        1. 3A58010674
        verification flags
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        2. spl_text_not_verified_identical_to_latest_approved_label
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        Drugs@FDA application source records
        1. application number
          BLA761111
          payload
          all indexed label documents
          1. Appl No
            761111
            Application Docs Date
            2020-06-11 00:00:00
            Application Docs ID
            63481
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            761111
            Application Docs Date
            2021-04-19 00:00:00
            Application Docs ID
            67098
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            4
            Submission Type
            SUPPL
          3. Appl No
            761111
            Application Docs Date
            2026-05-26 00:00:00
            Application Docs ID
            86019
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            10
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            761111
            Review Priority
            STANDARD
            Submission Class Code ID
            9
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2020-06-10 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            761111
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            4
            Submission Status
            AP
            Submission Status Date
            2021-04-16 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            761111
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            10
            Submission Status
            AP
            Submission Status Date
            2026-05-21 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          BLA761111
          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
          2026-05-21
          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
            761111
            Application Docs Date
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            Application Docs ID
            86019
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
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            Submission Type
            SUPPL
          official application record
          Appl No
          761111
          Appl Public Notes
          Appl Type
          BLA
          Sponsor Name
          HOSPIRA INC
          openfda application present
          true
          products
          1. Active Ingredient
            PEGFILGRASTIM-APGF
            Appl No
            761111
            Drug Name
            NYVEPRIA
            Form
            INJECTABLE;INJECTION
            Product No
            001
            Reference Drug
            0
            Reference Standard
            0
            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. BLA761111
        brand names
        1. NYVEPRIA
        classification reasons
        1. explicit_positive_indication_predicate
        2. supportive_or_complication_use_words
        clinical review status
        pending
        content role
        positive_indication_candidate
        context span
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        668
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE Patients with Cancer Receiving Myelosuppressive Chemotherapy NYVEPRIA is indicated in adults and pediatric patients aged newborn and older 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 Dosage and Administration (2.1) and Clinical Studies (14) ] . NYVEPRIA is a leukocyte growth factor indicated in adults and pediatric patients aged newborn and older to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with
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        qualifier mentions
        1. context exact
          ving Myelosuppressive Chemotherapy NYVEPRIA is indicated in adults and pediatric patients aged newborn and older to decrease t
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          not_inferred
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        2. context exact
          uppressive Chemotherapy NYVEPRIA is indicated in adults and pediatric patients aged newborn and older to decrease the incidence of infecti
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            1 INDICATIONS AND USAGE Patients with Cancer Receiving Myelosuppressive Chemotherapy NYVEPRIA is indicated in adults and pediatric patients aged newborn and older 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 Dosage and Administration (2.1) and Clinical Studies (14) ] .
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            spl effective date
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            Source null
            limitations
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            tumor histology
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            use intent
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            application numbers
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            brand names
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            exact text
            malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia [see Dosage and Administration (2.1) and Clinical Studies (14) ] . NYVEPRIA is a leukocyte growth factor indicated in adults and pediatric patients aged newborn and older 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 ) Limitations of Use NYVEPRIA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. ( 1 ) Limitations of Use NYVEPRIA is not indi
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            is a leukocyte growth factor indicated
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              NYVEPRIA is a leukocyte growth factor indicated in adults and pediatric patients aged newborn and older to decrease t
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              not_inferred
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              VEPRIA is a leukocyte growth factor indicated in adults and pediatric patients aged newborn and older to decrease the incidence of infecti
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                NYVEPRIA is a leukocyte growth factor indicated in adults and pediatric patients aged newborn and older 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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                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 ) Limitations of Use NYVEPRIA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. ( 1 ) Limitations of Use NYVEPRIA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
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                      significant incidence of febrile neutropenia. ( 1 ) Limitations of Use NYVEPRIA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. ( 1 ) Limitations of Use NYVEPRIA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
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                            ( 1 ) Limitations of Use NYVEPRIA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
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                            https://api.fda.gov/drug/label.json?search=id%3A%22e562b389-581e-4cf2-a09d-0bd6093d9027%22
                            spl effective date
                            2026-06-02
                            spl set id
                            99d30b99-2743-446b-98f3-0430bf4ea869
                            spl version
                            9
                            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

                            Preserved source evidence · Not medical advice