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LABELS · 523867f4-dbc4-1258-e063-6394a90a3145

RYZNEUTA

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
2026-05-19
Captured
2026-09-09T23:37:47.659725+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1. INDICATIONS AND USAGE RYZNEUTA is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Limitations of Use RYZNEUTA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. RYZNEUTA is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. ( 1 ) Limitations of Use RYZNEUTA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. ( 1 )
Full extracted label fields
application numbers
  1. BLA761134
boxed warning exact
    brand names
    1. RYZNEUTA
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=290ed754-758c-9cae-e063-6294a90ae68b
    generic names
    1. EFBEMALENOGRASTIM ALFA-VUXW
    id
    523867f4-dbc4-1258-e063-6394a90a3145
    indications and usage exact
    1. 1. INDICATIONS AND USAGE RYZNEUTA is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Limitations of Use RYZNEUTA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. RYZNEUTA is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. ( 1 ) Limitations of Use RYZNEUTA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Acrotech Biopharma Inc
      matched search terms
      1. cancer
      package ndcs
      1. 72893-016-02
      product ndcs
      1. 72893-016
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. SUBCUTANEOUS
        rxcuis
        1. 2670662
        2. 2670669
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00300.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
        results
        limit
        100
        skip
        300
        total
        830
        sha256
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        url
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        source url
        https://api.fda.gov/drug/label.json?search=id%3A%22523867f4-dbc4-1258-e063-6394a90a3145%22
        spl effective date
        2026-05-19
        spl effective time
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        spl set id
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        spl version
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        substance names
        1. EFBEMALENOGRASTIM ALFA
        uniis
        1. 5UPW5HJW3O
        verification flags
        1. oncology_keyword_candidate_not_clinically_classified
        2. spl_text_not_verified_identical_to_latest_approved_label
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        Drugs@FDA application source records
        1. application number
          BLA761134
          payload
          all indexed label documents
          1. Appl No
            761134
            Application Docs Date
            2023-11-17 00:00:00
            Application Docs ID
            76606
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          all submission records
          1. Appl No
            761134
            Review Priority
            STANDARD
            Submission Class Code ID
            7
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2023-11-16 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          application number
          BLA761134
          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
          2023-11-16
          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
          1. Appl No
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            Application Docs Date
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            Application Docs ID
            76606
            Application Docs Title
            0
            Application Docs Type ID
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            Submission No
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            Submission Type
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          official application record
          Appl No
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          Appl Public Notes
          Appl Type
          BLA
          Sponsor Name
          EVIVE BIOTECHNOLOGY
          openfda application present
          true
          products
          1. Active Ingredient
            EFBEMALENOGRASTIM ALFA-VUXW
            Appl No
            761134
            Drug Name
            RYZNEUTA
            Form
            INJECTABLE;INJECTION
            Product No
            001
            Reference Drug
            0
            Reference Standard
            0
            Strength
            20MG/ML
            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 · unclassified context
        application numbers
        1. BLA761134
        brand names
        1. RYZNEUTA
        classification reasons
        1. no_unambiguous_positive_indication_predicate
        clinical review status
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        true
        exact text
        1. INDICATIONS AND USAGE RYZNEUTA is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive an
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        generic names
        1. EFBEMALENOGRASTIM ALFA-VUXW
        id
        ind-span-7657c41f8ee930c5b74b
        label id
        523867f4-dbc4-1258-e063-6394a90a3145
        positive predicate support span
        Source null
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              source url
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              spl effective date
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              spl set id
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              structured fields status
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              tumor histology
              Source null
              use intent
              unclear
              Passage 2 · positive indication candidate
              application numbers
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              brand names
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              classification reasons
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              exact text
              1. INDICATIONS AND USAGE RYZNEUTA is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Limitations of Use RYZNEUTA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. RYZNEUTA is a leukocyte growth factor indicated to
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              qualifier mentions
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                ence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive an
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                  exact text
                  INDICATIONS AND USAGE RYZNEUTA is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
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                  limitations
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                  prior therapy
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                  tumor histology
                  Source null
                  use intent
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                  application numbers
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                  exact text
                  ifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Limitations of Use RYZNEUTA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. RYZNEUTA is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressiv
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                  generic names
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                  id
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                  positive predicate support span
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                        exact text
                        Limitations of Use RYZNEUTA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
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                        source url
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                        spl effective date
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                        spl set id
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                        limitations
                        Source null
                        line
                        Source null
                        prior therapy
                        Source null
                        regimen
                        Source null
                        tumor histology
                        Source null
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                        Passage 4 · positive indication candidate
                        application numbers
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                        brand names
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                        end exclusive
                        true
                        exact text
                        cally significant incidence of febrile neutropenia. Limitations of Use RYZNEUTA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. RYZNEUTA is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. ( 1 ) Limitations of Use RYZNEUTA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. ( 1 )
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                        is a leukocyte growth factor indicated
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                            RYZNEUTA is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
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                            exact text
                            ifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. ( 1 ) Limitations of Use RYZNEUTA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. ( 1 )
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                                  exact text
                                  ( 1 ) Limitations of Use RYZNEUTA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
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                                  66b748b19e34423d47a0493768ed0f4e5751f68129de8d24ec6afb777732a678
                                  start
                                  735
                                  source url
                                  https://api.fda.gov/drug/label.json?search=id%3A%22523867f4-dbc4-1258-e063-6394a90a3145%22
                                  spl effective date
                                  2026-05-19
                                  spl set id
                                  290ed754-758c-9cae-e063-6294a90ae68b
                                  spl version
                                  7
                                  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
                                  Passage 6 · unclassified context
                                  application numbers
                                  1. BLA761134
                                  brand names
                                  1. RYZNEUTA
                                  classification reasons
                                  1. no_unambiguous_positive_indication_predicate
                                  clinical review status
                                  pending
                                  content role
                                  unclassified_context
                                  context span
                                  end
                                  894
                                  end exclusive
                                  true
                                  exact text
                                  significant incidence of febrile neutropenia. ( 1 ) Limitations of Use RYZNEUTA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. ( 1 )
                                  label id
                                  523867f4-dbc4-1258-e063-6394a90a3145
                                  offset unit
                                  unicode_code_points
                                  source array index
                                  0
                                  source field
                                  indications_and_usage_exact
                                  source text sha256
                                  66b748b19e34423d47a0493768ed0f4e5751f68129de8d24ec6afb777732a678
                                  start
                                  689
                                  current approval status
                                  not_reconciled
                                  duplicate text group
                                  dup-c8e454c4bfbb564bdb58
                                  extraction review status
                                  automated_candidate_pending_source_review
                                  generic names
                                  1. EFBEMALENOGRASTIM ALFA-VUXW
                                  id
                                  ind-span-1b39fa524b62f8bb1df5
                                  label id
                                  523867f4-dbc4-1258-e063-6394a90a3145
                                  positive predicate support span
                                  Source null
                                  qualifier mentions
                                    regulatory links
                                      schema version
                                      0.1.0
                                      source batch sha256
                                      bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
                                      source defined aliases
                                        source span
                                        end
                                        894
                                        end exclusive
                                        true
                                        exact text
                                        ( 1 )
                                        label id
                                        523867f4-dbc4-1258-e063-6394a90a3145
                                        offset unit
                                        unicode_code_points
                                        source array index
                                        0
                                        source field
                                        indications_and_usage_exact
                                        source text sha256
                                        66b748b19e34423d47a0493768ed0f4e5751f68129de8d24ec6afb777732a678
                                        start
                                        889
                                        source url
                                        https://api.fda.gov/drug/label.json?search=id%3A%22523867f4-dbc4-1258-e063-6394a90a3145%22
                                        spl effective date
                                        2026-05-19
                                        spl set id
                                        290ed754-758c-9cae-e063-6294a90ae68b
                                        spl version
                                        7
                                        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
                                        unclear

                                        Preserved source evidence · Not medical advice