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LABELS · 8cba79e2-11fa-4eb9-87e7-827ca781fbf3

VIDAZA

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
2024-01-29
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 VIDAZA is a nucleoside metabolic inhibitor indicated for the treatment of: • Adult patients with the following FAB myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL). ( 1.1 ) • Pediatric patients aged 1 month and older with newly diagnosed Juvenile Myelomonocytic Leukemia (JMML). ( 1.2 ) 1.1 Myelodysplastic Syndromes (MDS) VIDAZA ® is indicated for treatment of adult patients with the following French-American-British (FAB) myelodysplastic syndrome subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL). 1.2 Juvenile Myelomonocytic Leukemia (JMML) VIDAZA is indicated for the treatment of pediatric patients aged one month and older with newly diagnosed JMML.
Full extracted label fields
application numbers
  1. NDA050794
boxed warning exact
    brand names
    1. VIDAZA
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3495a71a-cc04-4776-851f-f185956f32af
    generic names
    1. AZACITIDINE
    id
    8cba79e2-11fa-4eb9-87e7-827ca781fbf3
    indications and usage exact
    1. 1 INDICATIONS AND USAGE VIDAZA is a nucleoside metabolic inhibitor indicated for the treatment of: • Adult patients with the following FAB myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL). ( 1.1 ) • Pediatric patients aged 1 month and older with newly diagnosed Juvenile Myelomonocytic Leukemia (JMML). ( 1.2 ) 1.1 Myelodysplastic Syndromes (MDS) VIDAZA ® is indicated for treatment of adult patients with the following French-American-British (FAB) myelodysplastic syndrome subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL). 1.2 Juvenile Myelomonocytic Leukemia (JMML) VIDAZA is indicated for the treatment of pediatric patients aged one month and older with newly diagnosed JMML.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Celgene Corporation
      matched search terms
      1. leukemia
      2. myelodysplastic
      package ndcs
      1. 59572-102-01
      product ndcs
      1. 59572-102
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. INTRAVENOUS
        2. SUBCUTANEOUS
        rxcuis
        1. 485246
        2. 545206
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00500.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
        500
        total
        830
        sha256
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        url
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        source url
        https://api.fda.gov/drug/label.json?search=id%3A%228cba79e2-11fa-4eb9-87e7-827ca781fbf3%22
        spl effective date
        2024-01-29
        spl effective time
        20240129
        spl set id
        3495a71a-cc04-4776-851f-f185956f32af
        spl version
        22
        substance names
        1. AZACITIDINE
        uniis
        1. M801H13NRU
        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
          NDA050794
          payload
          all indexed label documents
          1. Appl No
            050794
            Application Docs Date
            2004-05-19 00:00:00
            Application Docs ID
            18265
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            050794
            Application Docs Date
            2011-08-24 00:00:00
            Application Docs ID
            18266
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            16
            Submission Type
            SUPPL
          3. Appl No
            050794
            Application Docs Date
            2014-01-13 00:00:00
            Application Docs ID
            18267
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            26
            Submission Type
            SUPPL
          4. Appl No
            050794
            Application Docs Date
            2007-02-02 00:00:00
            Application Docs ID
            39344
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            5
            Submission Type
            SUPPL
          5. Appl No
            050794
            Application Docs Date
            2008-08-26 00:00:00
            Application Docs ID
            39345
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            11
            Submission Type
            SUPPL
          6. Appl No
            050794
            Application Docs Date
            2011-08-24 00:00:00
            Application Docs ID
            39346
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            20
            Submission Type
            SUPPL
          7. Appl No
            050794
            Application Docs Date
            2012-01-25 00:00:00
            Application Docs ID
            39347
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            23
            Submission Type
            SUPPL
          8. Appl No
            050794
            Application Docs Date
            2012-12-21 00:00:00
            Application Docs ID
            39348
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            24
            Submission Type
            SUPPL
          9. Appl No
            050794
            Application Docs Date
            2015-12-24 00:00:00
            Application Docs ID
            39349
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            28
            Submission Type
            SUPPL
          10. Appl No
            050794
            Application Docs Date
            2016-08-23 00:00:00
            Application Docs ID
            45198
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            29
            Submission Type
            SUPPL
          11. Appl No
            050794
            Application Docs Date
            2018-08-02 00:00:00
            Application Docs ID
            55071
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            31
            Submission Type
            SUPPL
          12. Appl No
            050794
            Application Docs Date
            2020-03-19 00:00:00
            Application Docs ID
            62189
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            32
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            050794
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            36
            Submission Status
            AP
            Submission Status Date
            2024-06-28 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          2. Appl No
            050794
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            35
            Submission Status
            AP
            Submission Status Date
            2022-09-23 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            050794
            Review Priority
            PRIORITY
            Submission Class Code ID
            2
            Submission No
            34
            Submission Status
            AP
            Submission Status Date
            2022-05-20 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            050794
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            32
            Submission Status
            AP
            Submission Status Date
            2020-03-18 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            050794
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            31
            Submission Status
            AP
            Submission Status Date
            2018-07-20 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            050794
            Review Priority
            STANDARD
            Submission Class Code ID
            4
            Submission No
            30
            Submission Status
            AP
            Submission Status Date
            2017-01-30 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            050794
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            29
            Submission Status
            AP
            Submission Status Date
            2016-08-23 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            050794
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            28
            Submission Status
            AP
            Submission Status Date
            2015-12-17 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          9. Appl No
            050794
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            27
            Submission Status
            AP
            Submission Status Date
            2015-02-23 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          10. Appl No
            050794
            Review Priority
            UNKNOWN
            Submission Class Code ID
            3
            Submission No
            26
            Submission Status
            AP
            Submission Status Date
            2014-01-10 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          11. Appl No
            050794
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            25
            Submission Status
            AP
            Submission Status Date
            2013-05-06 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          12. Appl No
            050794
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            24
            Submission Status
            AP
            Submission Status Date
            2012-12-19 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA050794
          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
          2024-06-28
          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
            050794
            Application Docs Date
            2024-07-02 00:00:00
            Application Docs ID
            78960
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            36
            Submission Type
            SUPPL
          official application record
          Appl No
          050794
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          BRISTOL-MYERS
          openfda application present
          true
          products
          1. Active Ingredient
            AZACITIDINE
            Appl No
            050794
            Drug Name
            VIDAZA
            Form
            POWDER;INTRAVENOUS, SUBCUTANEOUS
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            Strength
            100MG/VIAL
            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. NDA050794
        brand names
        1. VIDAZA
        classification reasons
        1. explicit_positive_indication_predicate
        2. no_tumor_directed_keyword_in_positive_statement
        clinical review status
        pending
        content role
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        context span
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        298
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        true
        exact text
        1 INDICATIONS AND USAGE VIDAZA is a nucleoside metabolic inhibitor indicated for the treatment of: • Adult patients with the following FAB myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thromboc
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        duplicate text group
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        generic names
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        is a nucleoside metabolic inhibitor indicated
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        qualifier mentions
        1. context exact
          1 INDICATIONS AND USAGE VIDAZA is a nucleoside metabolic inhibitor indicated for the treatment of:
          kind
          biomarker
          polarity
          not_inferred
          span
          end
          90
          end exclusive
          true
          exact text
          metabolic inhibitor indicated for the treat
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            1 INDICATIONS AND USAGE VIDAZA is a nucleoside metabolic inhibitor indicated for the treatment of:
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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
            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
            non_oncology_or_unclear_candidate
            Passage 2 · positive indication candidate
            application numbers
            1. NDA050794
            brand names
            1. VIDAZA
            classification reasons
            1. inherited_predicate_from_same_label_section_requires_review
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            exact text
            1 INDICATIONS AND USAGE VIDAZA is a nucleoside metabolic inhibitor indicated for the treatment of: • Adult patients with the following FAB myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL). ( 1.1 ) • Pediatric patients aged 1 month and older with newly diagnosed Juvenile Myelomonocytic Leukemia (JMML). ( 1.2 ) 1.1 Myelodysplastic Syndromes (MDS) VIDAZA ® is indicated for treatment of ad
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            qualifier mentions
            1. context exact
              • Adult patients with the following FAB myelodysplastic syndrome (MDS) subty
              kind
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              polarity
              not_inferred
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              end exclusive
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              Adult patients
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            4. context exact
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            regulatory links
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                • Adult patients with the following FAB myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL).
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                source url
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                                        Preserved source evidence · Not medical advice