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LABELS · 1e0e90a7-6205-4ed2-b315-4b884da070a3

ZIEXTENZO

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
2026-05-14
Captured
2026-09-09T23:37:42.544548+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE ZIEXTENZO 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 ZIEXTENZO is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy ZIEXTENZO 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 Clinical Studies ( 14.1 )]. Limitations of Use ZIEXTENZO 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 ZIEXTENZO is indicated to increase survival in adults and pediatric patients aged newborn and older 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. BLA761045
boxed warning exact
    brand names
    1. ZIEXTENZO
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7dada041-6528-4acf-809c-62d271538c9a
    generic names
    1. PEGFILGRASTIM-BMEZ
    id
    1e0e90a7-6205-4ed2-b315-4b884da070a3
    indications and usage exact
    1. 1 INDICATIONS AND USAGE ZIEXTENZO 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 ZIEXTENZO is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy ZIEXTENZO 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 Clinical Studies ( 14.1 )]. Limitations of Use ZIEXTENZO 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 ZIEXTENZO is indicated to increase survival in adults and pediatric patients aged newborn and older 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. Sandoz Inc
      matched search terms
      1. cancer
      package ndcs
      1. 61314-866-01
      2. 61314-866-02
      product ndcs
      1. 61314-866
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. SUBCUTANEOUS
        rxcuis
        1. 2260704
        2. 2260709
        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
        100
        total
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        url
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        source url
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        spl effective date
        2026-05-14
        spl effective time
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        spl set id
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        spl version
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        substance names
        1. PEGFILGRASTIM
        uniis
        1. 3A58010674
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        Drugs@FDA application source records
        1. application number
          BLA761045
          payload
          all indexed label documents
          1. Appl No
            761045
            Application Docs Date
            2019-11-05 00:00:00
            Application Docs ID
            60781
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            761045
            Application Docs Date
            2021-03-15 00:00:00
            Application Docs ID
            66780
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            6
            Submission Type
            SUPPL
          3. Appl No
            761045
            Application Docs Date
            2023-10-10 00:00:00
            Application Docs ID
            75700
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            11
            Submission Type
            SUPPL
          4. Appl No
            761045
            Application Docs Date
            2024-02-29 00:00:00
            Application Docs ID
            77651
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            14
            Submission Type
            SUPPL
          5. Appl No
            761045
            Application Docs Date
            2026-05-18 00:00:00
            Application Docs ID
            85941
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            17
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            761045
            Review Priority
            STANDARD
            Submission Class Code ID
            15
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2019-11-04 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            761045
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            6
            Submission Status
            AP
            Submission Status Date
            2021-03-12 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
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            Review Priority
            N/A
            Submission Class Code ID
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            Submission No
            11
            Submission Status
            AP
            Submission Status Date
            2023-10-09 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            761045
            Review Priority
            Submission Class Code ID
            28
            Submission No
            14
            Submission Status
            AP
            Submission Status Date
            2024-02-28 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            761045
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            17
            Submission Status
            AP
            Submission Status Date
            2026-05-12 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          BLA761045
          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
          2026-05-12
          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
            761045
            Application Docs Date
            2026-05-18 00:00:00
            Application Docs ID
            85941
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            17
            Submission Type
            SUPPL
          official application record
          Appl No
          761045
          Appl Public Notes
          Appl Type
          BLA
          Sponsor Name
          SANDOZ INC
          openfda application present
          true
          products
          1. Active Ingredient
            PEGFILGRASTIM-BMEZ
            Appl No
            761045
            Drug Name
            ZIEXTENZO
            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. BLA761045
        brand names
        1. ZIEXTENZO
        classification reasons
        1. explicit_positive_indication_predicate
        2. no_tumor_directed_keyword_in_positive_statement
        clinical review status
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        context span
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        275
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE ZIEXTENZO 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 signif
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        is a leukocyte growth factor indicated
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              1 INDICATIONS AND USAGE ZIEXTENZO is a leukocyte growth factor indicated to
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              tumor histology
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              exact text
              1 INDICATIONS AND USAGE ZIEXTENZO 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 ZIEXTENZO is not ind
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              positive predicate support span
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                    • 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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                    spl effective date
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                    biomarker and test
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                    tumor histology
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                    use intent
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                    Passage 3 · unclassified context
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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 ZIEXTENZO is not indicated f
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                          spl effective date
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                          Passage 4 · unclassified context
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                          ested 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 ZIEXTENZO is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosu
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                                • Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).
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                                approval pathway
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                                limitations
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                                regimen
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                                use intent
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                                Passage 5 · limitation of use
                                application numbers
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                                brand names
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                                classification reasons
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                                exact text
                                y 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 ZIEXTENZO is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy ZIEXTENZO is indicated in adults and pediatric patients aged newborn and older to decrease the incidence of infection, as manifested b
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                                                    Preserved source evidence · Not medical advice