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LABELS · 32634006-49db-4043-b84b-65f7f54b142d

Idhifa

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
2025-01-16
Captured
2026-09-09T23:37:42.544548+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: DIFFERENTIATION SYNDROME Patients treated with IDHIFA have experienced symptoms of differentiation syndrome, which can be fatal if not treated. Symptoms may include fever, dyspnea, acute respiratory distress, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, lymphadenopathy, bone pain, and hepatic, renal, or multi-organ dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] . WARNING: DIFFERENTIATION SYNDROME See full prescribing information for complete boxed warning. Patients treated with IDHIFA have experienced symptoms of differentiation syndrome, which can be fatal if not treated. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution ( 5.1 , 6.1 ).

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE IDHIFA is an isocitrate dehydrogenase-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test ( 1.1 ). 1.1 Acute Myeloid Leukemia IDHIFA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test.
Full extracted label fields
application numbers
  1. NDA209606
boxed warning exact
  1. WARNING: DIFFERENTIATION SYNDROME Patients treated with IDHIFA have experienced symptoms of differentiation syndrome, which can be fatal if not treated. Symptoms may include fever, dyspnea, acute respiratory distress, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, lymphadenopathy, bone pain, and hepatic, renal, or multi-organ dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] . WARNING: DIFFERENTIATION SYNDROME See full prescribing information for complete boxed warning. Patients treated with IDHIFA have experienced symptoms of differentiation syndrome, which can be fatal if not treated. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution ( 5.1 , 6.1 ).
brand names
  1. Idhifa
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a5b4cdf0-3fa8-4c6c-80f6-8d8a00e3a5b6
generic names
  1. ENASIDENIB MESYLATE
id
32634006-49db-4043-b84b-65f7f54b142d
indications and usage exact
  1. 1 INDICATIONS AND USAGE IDHIFA is an isocitrate dehydrogenase-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test ( 1.1 ). 1.1 Acute Myeloid Leukemia IDHIFA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test.
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Celgene Corporation
    matched search terms
    1. leukemia
    package ndcs
    1. 59572-705-30
    2. 59572-710-30
    product ndcs
    1. 59572-705
    2. 59572-710
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
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      1. ORAL
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      1. 1940370
      2. 1940372
      3. 1940374
      4. 1940376
      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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      sha256
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      url
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      source url
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      spl effective date
      2025-01-16
      spl effective time
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      substance names
      1. ENASIDENIB MESYLATE
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      Drugs@FDA application source records
      1. application number
        NDA209606
        payload
        all indexed label documents
        1. Appl No
          209606
          Application Docs Date
          2017-08-01 00:00:00
          Application Docs ID
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          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          209606
          Application Docs Date
          2019-10-01 00:00:00
          Application Docs ID
          60185
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          2
          Submission Type
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        3. Appl No
          209606
          Application Docs Date
          2020-11-25 00:00:00
          Application Docs ID
          65332
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          4
          Submission Type
          SUPPL
        4. Appl No
          209606
          Application Docs Date
          2023-12-22 00:00:00
          Application Docs ID
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          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          6
          Submission Type
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        5. Appl No
          209606
          Application Docs Date
          2024-12-19 00:00:00
          Application Docs ID
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          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          8
          Submission Type
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        6. Appl No
          209606
          Application Docs Date
          2025-01-17 00:00:00
          Application Docs ID
          80863
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          7
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          209606
          Review Priority
          PRIORITY
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2017-08-01 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          209606
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          2
          Submission Status
          AP
          Submission Status Date
          2019-09-27 00:00:00
          Submission Type
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          Submissions Public Notes
        3. Appl No
          209606
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          4
          Submission Status
          AP
          Submission Status Date
          2020-11-24 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          209606
          Review Priority
          N/A
          Submission Class Code ID
          4
          Submission No
          5
          Submission Status
          AP
          Submission Status Date
          2021-07-26 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          209606
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          6
          Submission Status
          AP
          Submission Status Date
          2023-12-21 00:00:00
          Submission Type
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          Submissions Public Notes
        6. Appl No
          209606
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          7
          Submission Status
          AP
          Submission Status Date
          2025-01-16 00:00:00
          Submission Type
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          Submissions Public Notes
        7. Appl No
          209606
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          8
          Submission Status
          AP
          Submission Status Date
          2024-12-18 00:00:00
          Submission Type
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          Submissions Public Notes
        application number
        NDA209606
        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
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        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
          80863
          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
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        Sponsor Name
        BRISTOL MYERS SQUIBB
        openfda application present
        true
        products
        1. Active Ingredient
          ENASIDENIB MESYLATE
          Appl No
          209606
          Drug Name
          IDHIFA
          Form
          TABLET;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          0
          Strength
          EQ 50MG BASE
          marketing status
          1. Prescription
        2. Active Ingredient
          ENASIDENIB MESYLATE
          Appl No
          209606
          Drug Name
          IDHIFA
          Form
          TABLET;ORAL
          Product No
          002
          Reference Drug
          1
          Reference Standard
          1
          Strength
          EQ 100MG BASE
          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. NDA209606
      brand names
      1. Idhifa
      classification reasons
      1. explicit_positive_indication_predicate
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      true
      exact text
      1 INDICATIONS AND USAGE IDHIFA is an isocitrate dehydrogenase-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test ( 1.1 ). 1.1 Acute Myeloid Leukemia IDHIFA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detec
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      1. ENASIDENIB MESYLATE
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      is an isocitrate dehydrogenase-2 inhibitor indicated
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      1. context exact
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      2. context exact
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      3. context exact
        nhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation
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        exact text
        relapsed or refractory acute myeloid leukem
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        source defined aliases
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          true
          exact text
          1 INDICATIONS AND USAGE IDHIFA is an isocitrate dehydrogenase-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test ( 1.1 ).
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          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
          tumor_directed_candidate
          Passage 2 · positive indication candidate
          application numbers
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          exact text
          indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test ( 1.1 ). 1.1 Acute Myeloid Leukemia IDHIFA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test.
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            DHIFA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation
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              1.1 Acute Myeloid Leukemia IDHIFA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test.
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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