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LABELS · 25abb1d8-f921-4aae-8240-1914cd80417a

VYXEOS

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
2026-01-30
Captured
2026-09-09T23:37:42.544548+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: DO NOT INTERCHANGE WITH OTHER DAUNORUBICIN AND/OR CYTARABINE-CONTAINING PRODUCTS • VYXEOS has different dosage recommendations than daunorubicin hydrochloride injection, cytarabine injection, daunorubicin citrate liposome injection, and cytarabine liposome injection. Verify drug name and dose prior to preparation and administration to avoid dosing errors [see Warnings and Precautions ( 5.1 )] . WARNING: DO NOT INTERCHANGE WITH OTHER DAUNORUBICIN AND/OR CYTARABINE-CONTAINING PRODUCTS See full prescribing information for complete boxed warning. • VYXEOS has different dosage recommendations than daunorubicin hydrochloride injection, cytarabine injection, daunorubicin citrate liposome injection, and cytarabine liposome injection. Verify drug name and dose prior to preparation and administration to avoid dosing errors ( 5.1 ).

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE VYXEOS is indicated for the treatment of newly diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older. VYXEOS is a liposomal combination of daunorubicin, an anthracycline topoisomerase inhibitor, and cytarabine, a nucleoside metabolic inhibitor, that is indicated for the treatment of newly diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older. ( 1 )
Full extracted label fields
application numbers
  1. NDA209401
boxed warning exact
  1. WARNING: DO NOT INTERCHANGE WITH OTHER DAUNORUBICIN AND/OR CYTARABINE-CONTAINING PRODUCTS • VYXEOS has different dosage recommendations than daunorubicin hydrochloride injection, cytarabine injection, daunorubicin citrate liposome injection, and cytarabine liposome injection. Verify drug name and dose prior to preparation and administration to avoid dosing errors [see Warnings and Precautions ( 5.1 )] . WARNING: DO NOT INTERCHANGE WITH OTHER DAUNORUBICIN AND/OR CYTARABINE-CONTAINING PRODUCTS See full prescribing information for complete boxed warning. • VYXEOS has different dosage recommendations than daunorubicin hydrochloride injection, cytarabine injection, daunorubicin citrate liposome injection, and cytarabine liposome injection. Verify drug name and dose prior to preparation and administration to avoid dosing errors ( 5.1 ).
brand names
  1. VYXEOS
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7ea701ce-e7d3-4349-a9c2-642a501d45c8
generic names
  1. (DAUNORUBICIN AND CYTARABINE) LIPOSOME
id
25abb1d8-f921-4aae-8240-1914cd80417a
indications and usage exact
  1. 1 INDICATIONS AND USAGE VYXEOS is indicated for the treatment of newly diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older. VYXEOS is a liposomal combination of daunorubicin, an anthracycline topoisomerase inhibitor, and cytarabine, a nucleoside metabolic inhibitor, that is indicated for the treatment of newly diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older. ( 1 )
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Jazz Pharmaceuticals, Inc.
    matched search terms
    1. leukemia
    package ndcs
    1. 68727-745-05
    2. 68727-745-02
    3. 68727-745-01
    product ndcs
    1. 68727-745
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
      record type
      complete_spl_indications_section_candidate
      routes
      1. INTRAVENOUS
      rxcuis
      1. 1942743
      2. 1942748
      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
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      url
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      source url
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      spl effective date
      2026-01-30
      spl effective time
      20260130
      spl set id
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      spl version
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      substance names
      1. CYTARABINE
      2. DAUNORUBICIN
      uniis
      1. 04079A1RDZ
      2. ZS7284E0ZP
      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
        NDA209401
        payload
        all indexed label documents
        1. Appl No
          209401
          Application Docs Date
          2017-08-03 00:00:00
          Application Docs ID
          49218
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          209401
          Application Docs Date
          2021-03-30 00:00:00
          Application Docs ID
          66924
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          6
          Submission Type
          SUPPL
        3. Appl No
          209401
          Application Docs Date
          2022-09-28 00:00:00
          Application Docs ID
          72174
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          11
          Submission Type
          SUPPL
        4. Appl No
          209401
          Application Docs Date
          2026-01-28 00:00:00
          Application Docs ID
          84859
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          18
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          209401
          Review Priority
          PRIORITY
          Submission Class Code ID
          14
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2017-08-03 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          209401
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          2
          Submission Status
          AP
          Submission Status Date
          2020-01-13 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          209401
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          6
          Submission Status
          AP
          Submission Status Date
          2021-03-30 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          209401
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          11
          Submission Status
          AP
          Submission Status Date
          2022-09-27 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          209401
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          18
          Submission Status
          AP
          Submission Status Date
          2026-01-27 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA209401
        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
        2026-01-27
        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
          209401
          Application Docs Date
          2026-01-28 00:00:00
          Application Docs ID
          84859
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          18
          Submission Type
          SUPPL
        official application record
        Appl No
        209401
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        JAZZ PHARMS THERAP
        openfda application present
        true
        products
        1. Active Ingredient
          CYTARABINE; DAUNORUBICIN
          Appl No
          209401
          Drug Name
          VYXEOS
          Form
          POWDER;INTRAVENOUS
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
          Strength
          100MG;44MG
          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. NDA209401
      brand names
      1. VYXEOS
      classification reasons
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      2. tumor_or_malignant_hematology_words_in_positive_statement
      clinical review status
      pending
      content role
      positive_indication_candidate
      context span
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      431
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE VYXEOS is indicated for the treatment of newly diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older. VYXEOS is a liposomal combination of daunorubicin, an anthracycline topoisomerase inhibitor, and cytarabine, a nucleoside metabolic inhibitor, that is indicated for the treatment of newly diagnosed t
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      1. context exact
        ML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older.
        kind
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        not_inferred
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      2. context exact
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          exact text
          1 INDICATIONS AND USAGE VYXEOS is indicated for the treatment of newly diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older.
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          source url
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          spl effective date
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          spl set id
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          spl version
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          structured fields status
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          Source null
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          biomarker and test
          Source null
          disease stage
          Source null
          limitations
          Source null
          line
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          prior therapy
          Source null
          regimen
          Source null
          tumor histology
          Source null
          use intent
          tumor_directed_candidate
          Passage 2 · positive indication candidate
          application numbers
          1. NDA209401
          brand names
          1. VYXEOS
          classification reasons
          1. explicit_positive_indication_predicate
          2. tumor_or_malignant_hematology_words_in_positive_statement
          clinical review status
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          exact text
          s indicated for the treatment of newly diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older. VYXEOS is a liposomal combination of daunorubicin, an anthracycline topoisomerase inhibitor, and cytarabine, a nucleoside metabolic inhibitor, that is indicated for the treatment of newly diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older. ( 1 )
          label id
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          current approval status
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          extraction review status
          automated_candidate_pending_source_review
          generic names
          1. (DAUNORUBICIN AND CYTARABINE) LIPOSOME
          id
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          1. context exact
            ML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older.
            kind
            age
            polarity
            not_inferred
            span
            end
            539
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          2. context exact
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            not_inferred
            span
            end
            562
            end exclusive
            true
            exact text
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          3. context exact
            cline topoisomerase inhibitor, and cytarabine, a nucleoside metabolic inhibitor, that is indicated for the treatment of newly diagnosed the
            kind
            biomarker
            polarity
            not_inferred
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            metabolic inhibitor
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              exact text
              VYXEOS is a liposomal combination of daunorubicin, an anthracycline topoisomerase inhibitor, and cytarabine, a nucleoside metabolic inhibitor, that is indicated for the treatment of newly diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older.
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              tumor histology
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              application numbers
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              exact text
              s indicated for the treatment of newly diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older. ( 1 )
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                    source url
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                    limitations
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                    regimen
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                    use intent
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                    Preserved source evidence · Not medical advice