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LABELS · d504ef4f-8fe8-447e-8fb3-30846fb2e486

Idamycin PFS

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
2026-04-15
Captured
2026-09-09T23:37:58.719708+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: CARDIOMYOPATHY, SECONDARY MALIGNANCIES, and EXTRAVASATION AND TISSUE NECROSIS • Cardiomyopathy: IDAMYCIN PFS can cause myocardial damage, including acute left ventricular failure, during or after termination of therapy. The risk of cardiomyopathy is increased in patients who have received prior anthracyclines or who have pre-existing cardiac disease. Assess left ventricular cardiac function prior to initiation of IDAMYCIN PFS and during and after treatment [see Warnings and Precautions (5.1) ] . • Secondary Malignancies: Secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) occur at a higher incidence in patients treated with anthracyclines, including IDAMYCIN PFS [see Warnings and Precautions (5.2) ] . • Extravasation and Tissue Necrosis: Extravasation of IDAMYCIN PFS during administration can result in local tissue injury and necrosis. Immediately terminate the infusion of IDAMYCIN PFS and institute the recommended management procedures [see Dosage and Administration (2.6) and Warnings and Precautions (5.3) ] . WARNING: CARDIOMYOPATHY, SECONDARY MALIGNANCIES, and EXTRAVASATION AND TISSUE NECROSIS See full prescribing information for complete boxed warning. • Cardiomyopathy: Myocardial damage leading to congestive heart failure can occur with IDAMYCIN PFS. Assess left ventricular cardiac function prior to initiation of IDAMYCIN PFS and during and after treatment. (5.1) • Secondary Malignancies: Secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) occur at a higher incidence in patients treated with anthracyclines, including IDAMYCIN PFS. (5.2) • Extravasation of IDAMYCIN PFS during administration can result in local tissue injury and necrosis. Immediately discontinue the IDAMYCIN PFS infusion if extravasation occurs. ( 2.6 , 5.3 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE IDAMYCIN PFS is indicated for the treatment of adult patients with acute myeloid leukemia (AML) as a component of a combination chemotherapy regimen. IDAMYCIN PFS is an anthracycline topoisomerase inhibitor indicated for the treatment of adult patients with acute myeloid leukemia (AML) as a component of a combination chemotherapy regimen. (1)
Full extracted label fields
application numbers
  1. NDA050734
boxed warning exact
  1. WARNING: CARDIOMYOPATHY, SECONDARY MALIGNANCIES, and EXTRAVASATION AND TISSUE NECROSIS • Cardiomyopathy: IDAMYCIN PFS can cause myocardial damage, including acute left ventricular failure, during or after termination of therapy. The risk of cardiomyopathy is increased in patients who have received prior anthracyclines or who have pre-existing cardiac disease. Assess left ventricular cardiac function prior to initiation of IDAMYCIN PFS and during and after treatment [see Warnings and Precautions (5.1) ] . • Secondary Malignancies: Secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) occur at a higher incidence in patients treated with anthracyclines, including IDAMYCIN PFS [see Warnings and Precautions (5.2) ] . • Extravasation and Tissue Necrosis: Extravasation of IDAMYCIN PFS during administration can result in local tissue injury and necrosis. Immediately terminate the infusion of IDAMYCIN PFS and institute the recommended management procedures [see Dosage and Administration (2.6) and Warnings and Precautions (5.3) ] . WARNING: CARDIOMYOPATHY, SECONDARY MALIGNANCIES, and EXTRAVASATION AND TISSUE NECROSIS See full prescribing information for complete boxed warning. • Cardiomyopathy: Myocardial damage leading to congestive heart failure can occur with IDAMYCIN PFS. Assess left ventricular cardiac function prior to initiation of IDAMYCIN PFS and during and after treatment. (5.1) • Secondary Malignancies: Secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) occur at a higher incidence in patients treated with anthracyclines, including IDAMYCIN PFS. (5.2) • Extravasation of IDAMYCIN PFS during administration can result in local tissue injury and necrosis. Immediately discontinue the IDAMYCIN PFS infusion if extravasation occurs. ( 2.6 , 5.3 )
brand names
  1. Idamycin PFS
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0a5a6d93-cc1e-4d7f-8da1-446c134503b3
generic names
  1. IDARUBICIN HYDROCHLORIDE
id
d504ef4f-8fe8-447e-8fb3-30846fb2e486
indications and usage exact
  1. 1 INDICATIONS AND USAGE IDAMYCIN PFS is indicated for the treatment of adult patients with acute myeloid leukemia (AML) as a component of a combination chemotherapy regimen. IDAMYCIN PFS is an anthracycline topoisomerase inhibitor indicated for the treatment of adult patients with acute myeloid leukemia (AML) as a component of a combination chemotherapy regimen. (1)
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Pfizer Laboratories Div Pfizer Inc
    matched search terms
    1. leukemia
    package ndcs
    1. 0013-2576-91
    2. 0013-2576-05
    3. 0013-2586-91
    4. 0013-2586-10
    5. 0013-2596-91
    6. 0013-2596-20
    product ndcs
    1. 0013-2576
    2. 0013-2586
    3. 0013-2596
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
    1. Boxed Warning 2/2026 Indications and Usage (1) 2/2026 Dosage and Administration (2) 2/2026 Warnings and Precautions (5) 2/2026
    record type
    complete_spl_indications_section_candidate
    routes
    1. INTRAVENOUS
    rxcuis
    1. 1791493
    2. 1791495
    3. 1791498
    4. 1791499
    5. 1791500
    6. 1791501
    source batch
    file
    /private/tmp/cancer-full-research/indications/raw/labels-00600.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
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    skip
    600
    total
    830
    sha256
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    url
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    source url
    https://api.fda.gov/drug/label.json?search=id%3A%22d504ef4f-8fe8-447e-8fb3-30846fb2e486%22
    spl effective date
    2026-04-15
    spl effective time
    20260415
    spl set id
    0a5a6d93-cc1e-4d7f-8da1-446c134503b3
    spl version
    27
    substance names
    1. IDARUBICIN HYDROCHLORIDE
    uniis
    1. 5VV3MDU5IE
    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
      NDA050734
      payload
      all indexed label documents
      1. Appl No
        050734
        Application Docs Date
        2003-05-06 00:00:00
        Application Docs ID
        18144
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        5
        Submission Type
        SUPPL
      2. Appl No
        050734
        Application Docs Date
        2015-01-09 00:00:00
        Application Docs ID
        39217
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        22
        Submission Type
        SUPPL
      3. Appl No
        050734
        Application Docs Date
        2019-08-05 00:00:00
        Application Docs ID
        59573
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        25
        Submission Type
        SUPPL
      4. Appl No
        050734
        Application Docs Date
        2021-02-17 00:00:00
        Application Docs ID
        66248
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        27
        Submission Type
        SUPPL
      5. Appl No
        050734
        Application Docs Date
        2022-04-27 00:00:00
        Application Docs ID
        70839
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        29
        Submission Type
        SUPPL
      6. Appl No
        050734
        Application Docs Date
        2023-12-15 00:00:00
        Application Docs ID
        76870
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        31
        Submission Type
        SUPPL
      7. Appl No
        050734
        Application Docs Date
        2026-02-06 00:00:00
        Application Docs ID
        84963
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        32
        Submission Type
        SUPPL
      all submission records
      1. Appl No
        050734
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        32
        Submission Status
        AP
        Submission Status Date
        2026-02-06 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      2. Appl No
        050734
        Review Priority
        N/A
        Submission Class Code ID
        4
        Submission No
        31
        Submission Status
        AP
        Submission Status Date
        2023-11-06 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      3. Appl No
        050734
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        29
        Submission Status
        AP
        Submission Status Date
        2022-04-27 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      4. Appl No
        050734
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        27
        Submission Status
        AP
        Submission Status Date
        2021-02-10 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      5. Appl No
        050734
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        25
        Submission Status
        AP
        Submission Status Date
        2019-08-02 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      6. Appl No
        050734
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        22
        Submission Status
        AP
        Submission Status Date
        2014-12-04 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      7. Appl No
        050734
        Review Priority
        STANDARD
        Submission Class Code ID
        4
        Submission No
        11
        Submission Status
        AP
        Submission Status Date
        2002-11-05 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      8. Appl No
        050734
        Review Priority
        STANDARD
        Submission Class Code ID
        4
        Submission No
        10
        Submission Status
        AP
        Submission Status Date
        2002-04-02 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      9. Appl No
        050734
        Review Priority
        STANDARD
        Submission Class Code ID
        4
        Submission No
        9
        Submission Status
        AP
        Submission Status Date
        2000-11-21 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      10. Appl No
        050734
        Review Priority
        STANDARD
        Submission Class Code ID
        4
        Submission No
        8
        Submission Status
        AP
        Submission Status Date
        2000-05-31 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      11. Appl No
        050734
        Review Priority
        STANDARD
        Submission Class Code ID
        4
        Submission No
        7
        Submission Status
        AP
        Submission Status Date
        2000-05-31 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      12. Appl No
        050734
        Review Priority
        STANDARD
        Submission Class Code ID
        4
        Submission No
        6
        Submission Status
        AP
        Submission Status Date
        2000-04-07 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      application number
      NDA050734
      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
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      latest posted label documents
      1. Appl No
        050734
        Application Docs Date
        2026-02-06 00:00:00
        Application Docs ID
        84963
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        32
        Submission Type
        SUPPL
      official application record
      Appl No
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      Appl Public Notes
      Appl Type
      NDA
      Sponsor Name
      PFIZER
      openfda application present
      true
      products
      1. Active Ingredient
        IDARUBICIN HYDROCHLORIDE
        Appl No
        050734
        Drug Name
        IDAMYCIN PFS
        Form
        SOLUTION;INTRAVENOUS
        Product No
        001
        Reference Drug
        1
        Reference Standard
        1
        Strength
        5MG/5ML (1MG/ML)
        marketing status
        1. Prescription
      2. Active Ingredient
        IDARUBICIN HYDROCHLORIDE
        Appl No
        050734
        Drug Name
        IDARUBICIN HYDROCHLORIDE
        Form
        SOLUTION;INTRAVENOUS
        Product No
        002
        Reference Drug
        1
        Reference Standard
        1
        Strength
        10MG/10ML (1MG/ML)
        marketing status
        1. Prescription
      3. Active Ingredient
        IDARUBICIN HYDROCHLORIDE
        Appl No
        050734
        Drug Name
        IDARUBICIN HYDROCHLORIDE
        Form
        SOLUTION;INTRAVENOUS
        Product No
        003
        Reference Drug
        1
        Reference Standard
        1
        Strength
        20MG/20ML (1MG/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 · positive indication candidate
    application numbers
    1. NDA050734
    brand names
    1. Idamycin PFS
    classification reasons
    1. explicit_positive_indication_predicate
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    clinical review status
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    content role
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    end exclusive
    true
    exact text
    1 INDICATIONS AND USAGE IDAMYCIN PFS is indicated for the treatment of adult patients with acute myeloid leukemia (AML) as a component of a combination chemotherapy regimen. IDAMYCIN PFS is an anthracycline topoisomerase inhibitor indicated for the treatment of adult patients with acute myeloid leukemia (AML) as a component of a combination chemotherapy regimen. (1)
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    generic names
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    qualifier mentions
    1. context exact
      NS AND USAGE IDAMYCIN PFS is indicated for the treatment of adult patients with acute myeloid leukemia (AML) as a component of a combi
      kind
      age
      polarity
      not_inferred
      span
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      source defined aliases
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        1 INDICATIONS AND USAGE IDAMYCIN PFS is indicated for the treatment of adult patients with acute myeloid leukemia (AML) as a component of a combination chemotherapy regimen.
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        source url
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        spl effective date
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        Source null
        approval pathway
        Source null
        biomarker and test
        Source null
        disease stage
        Source null
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        Source null
        line
        Source null
        prior therapy
        Source null
        regimen
        Source null
        tumor histology
        Source null
        use intent
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        Passage 2 · positive indication candidate
        application numbers
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        1 INDICATIONS AND USAGE IDAMYCIN PFS is indicated for the treatment of adult patients with acute myeloid leukemia (AML) as a component of a combination chemotherapy regimen. IDAMYCIN PFS is an anthracycline topoisomerase inhibitor indicated for the treatment of adult patients with acute myeloid leukemia (AML) as a component of a combination chemotherapy regimen. (1)
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            IDAMYCIN PFS is an anthracycline topoisomerase inhibitor indicated for the treatment of adult patients with acute myeloid leukemia (AML) as a component of a combination chemotherapy regimen.
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            spl effective date
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            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
            tumor_directed_candidate
            Passage 3 · unclassified context
            application numbers
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            clinical review status
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                  Preserved source evidence · Not medical advice