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LABELS · ef242018-af2a-4c03-99b7-908e2610f86f

Mylotarg

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
2025-12-19
Captured
2026-09-09T23:38:02.384588+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: HEPATOTOXICITY Hepatotoxicity, including severe or fatal hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), has been reported in association with the use of MYLOTARG as a single agent, and as part of a combination chemotherapy regimen. Monitor frequently for signs and symptoms of VOD after treatment with MYLOTARG. ( 5.1 and 6.1 ) WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning. Hepatotoxicity, including severe or fatal hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), has been reported in association with the use of MYLOTARG. ( 5.1 , 6.1 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE MYLOTARG is a CD33-directed antibody and cytotoxic drug conjugate indicated for: • treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and older ( 1.1 ). • treatment of relapsed or refractory CD33-positive AML in adults and pediatric patients 2 years and older ( 1.2 ). 1.1 Newly-Diagnosed CD33-positive Acute Myeloid Leukemia (AML) MYLOTARG is indicated for the treatment of newly-diagnosed CD33-positive acute myeloid leukemia in adults and pediatric patients 1 month and older. 1.2 Relapsed or Refractory CD33-positive AML MYLOTARG is indicated for the treatment of relapsed or refractory CD33-positive acute myeloid leukemia in adults and pediatric patients 2 years and older.
Full extracted label fields
application numbers
  1. BLA761060
boxed warning exact
  1. WARNING: HEPATOTOXICITY Hepatotoxicity, including severe or fatal hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), has been reported in association with the use of MYLOTARG as a single agent, and as part of a combination chemotherapy regimen. Monitor frequently for signs and symptoms of VOD after treatment with MYLOTARG. ( 5.1 and 6.1 ) WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning. Hepatotoxicity, including severe or fatal hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), has been reported in association with the use of MYLOTARG. ( 5.1 , 6.1 )
brand names
  1. Mylotarg
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=32fd2bb2-1cfa-4250-feb8-d7956c794e05
generic names
  1. GEMTUZUMAB OZOGAMICIN
id
ef242018-af2a-4c03-99b7-908e2610f86f
indications and usage exact
  1. 1 INDICATIONS AND USAGE MYLOTARG is a CD33-directed antibody and cytotoxic drug conjugate indicated for: • treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and older ( 1.1 ). • treatment of relapsed or refractory CD33-positive AML in adults and pediatric patients 2 years and older ( 1.2 ). 1.1 Newly-Diagnosed CD33-positive Acute Myeloid Leukemia (AML) MYLOTARG is indicated for the treatment of newly-diagnosed CD33-positive acute myeloid leukemia in adults and pediatric patients 1 month and older. 1.2 Relapsed or Refractory CD33-positive AML MYLOTARG is indicated for the treatment of relapsed or refractory CD33-positive acute myeloid leukemia in adults and pediatric patients 2 years and older.
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
    matched search terms
    1. leukemia
    package ndcs
    1. 0008-4510-01
    product ndcs
    1. 0008-4510
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
    1. Dosage and Administration, Instructions for Reconstitution, Dilution, and Administration ( 2.4 ) 08/2021
    record type
    complete_spl_indications_section_candidate
    routes
    1. INTRAVENOUS
    rxcuis
    1. 1944701
    2. 1944704
    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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    total
    830
    sha256
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    url
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    source url
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    spl effective date
    2025-12-19
    spl effective time
    20251219
    spl set id
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    spl version
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    substance names
    1. GEMTUZUMAB OZOGAMICIN
    uniis
    1. 8GZG754X6M
    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
      BLA761060
      payload
      all indexed label documents
      1. Appl No
        761060
        Application Docs Date
        2017-09-01 00:00:00
        Application Docs ID
        49653
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        1
        Submission Type
        ORIG
      2. Appl No
        761060
        Application Docs Date
        2018-04-12 00:00:00
        Application Docs ID
        53663
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        1
        Submission Type
        SUPPL
      3. Appl No
        761060
        Application Docs Date
        2020-02-28 00:00:00
        Application Docs ID
        61989
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        3
        Submission Type
        SUPPL
      4. Appl No
        761060
        Application Docs Date
        2020-06-16 00:00:00
        Application Docs ID
        63575
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        4
        Submission Type
        SUPPL
      all submission records
      1. Appl No
        761060
        Review Priority
        PRIORITY
        Submission Class Code ID
        2
        Submission No
        4
        Submission Status
        AP
        Submission Status Date
        2020-06-16 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      2. Appl No
        761060
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        3
        Submission Status
        AP
        Submission Status Date
        2020-02-27 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      3. Appl No
        761060
        Review Priority
        STANDARD
        Submission Class Code ID
        2
        Submission No
        2
        Submission Status
        AP
        Submission Status Date
        2017-09-01 00:00:00
        Submission Type
        ORIG
        Submissions Public Notes
      4. Appl No
        761060
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        1
        Submission Status
        AP
        Submission Status Date
        2018-04-09 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      5. Appl No
        761060
        Review Priority
        STANDARD
        Submission Class Code ID
        14
        Submission No
        1
        Submission Status
        AP
        Submission Status Date
        2017-09-01 00:00:00
        Submission Type
        ORIG
        Submissions Public Notes
      application number
      BLA761060
      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
      2020-06-16
      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
        761060
        Application Docs Date
        2020-06-16 00:00:00
        Application Docs ID
        63575
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        4
        Submission Type
        SUPPL
      official application record
      Appl No
      761060
      Appl Public Notes
      Appl Type
      BLA
      Sponsor Name
      WYETH PHARMS INC
      openfda application present
      true
      products
      1. Active Ingredient
        GEMTUZUMAB OZOGAMICIN
        Appl No
        761060
        Drug Name
        MYLOTARG
        Form
        VIAL;SINGLE-DOSE
        Product No
        001
        Reference Drug
        0
        Reference Standard
        0
        Strength
        4.5MG
        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 · indication intro context
    application numbers
    1. BLA761060
    brand names
    1. Mylotarg
    classification reasons
    1. explicit_positive_indication_predicate
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    clinical review status
    pending
    content role
    indication_intro_context
    context span
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    304
    end exclusive
    true
    exact text
    1 INDICATIONS AND USAGE MYLOTARG is a CD33-directed antibody and cytotoxic drug conjugate indicated for: • treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and older ( 1.1 ). • treatment of relapsed or refractory CD33-positive AML in adults
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    exact text
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    qualifier mentions
    1. context exact
      1 INDICATIONS AND USAGE MYLOTARG is a CD33-directed antibody and cytotoxic drug conjugate indicated for:
      kind
      biomarker
      polarity
      not_inferred
      span
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      end exclusive
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      exact text
      CD33-directed antibody and cytotoxic drug co
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        1 INDICATIONS AND USAGE MYLOTARG is a CD33-directed antibody and cytotoxic drug conjugate indicated for:
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        source url
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        spl effective date
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        spl set id
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        disease stage
        Source null
        limitations
        Source null
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        Source null
        prior therapy
        Source null
        regimen
        Source null
        tumor histology
        Source null
        use intent
        not_applicable
        Passage 2 · positive indication candidate
        application numbers
        1. BLA761060
        brand names
        1. Mylotarg
        classification reasons
        1. inherited_predicate_from_same_label_section_requires_review
        2. tumor_or_malignant_hematology_words_in_positive_statement
        clinical review status
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        true
        exact text
        1 INDICATIONS AND USAGE MYLOTARG is a CD33-directed antibody and cytotoxic drug conjugate indicated for: • treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and older ( 1.1 ). • treatment of relapsed or refractory CD33-positive AML in adults and pediatric patients 2 years and older ( 1.2 ). 1.1 Newly-Diagnosed CD33-positive Acute Myeloid Leukemia (AML) MYLOTARG is indicate
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        label id
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        true
        exact text
        is a CD33-directed antibody and cytotoxic drug conjugate indicated
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        qualifier mentions
        1. context exact
          wly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and older ( 1.1 ).
          kind
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          polarity
          not_inferred
          span
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          end exclusive
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        2. context exact
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          kind
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          end
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          end exclusive
          true
          exact text
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        3. context exact
          • treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and older ( 1.1 ).
          kind
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          end exclusive
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          exact text
          CD33-positive acute myeloid leukemia (AML) i
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          source defined aliases
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            end exclusive
            true
            exact text
            • treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and older ( 1.1 ).
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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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            disease stage
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            limitations
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            Source null
            prior therapy
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            regimen
            Source null
            tumor histology
            Source null
            use intent
            tumor_directed_candidate
            Passage 3 · positive indication candidate
            application numbers
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            brand names
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            classification reasons
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            exact text
            D33-directed antibody and cytotoxic drug conjugate indicated for: • treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and older ( 1.1 ). • treatment of relapsed or refractory CD33-positive AML in adults and pediatric patients 2 years and older ( 1.2 ). 1.1 Newly-Diagnosed CD33-positive Acute Myeloid Leukemia (AML) MYLOTARG is indicated for the treatment of newly-diagnosed CD33-positive acute myeloid leukemia in adults and pediatric patients 1 month
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            is a CD33-directed antibody and cytotoxic drug conjugate indicated
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            qualifier mentions
            1. context exact
              • treatment of relapsed or refractory CD33-positive AML in adults and pediatric patients 2 years and older ( 1.2 ).
              kind
              age
              polarity
              not_inferred
              span
              end
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              end exclusive
              true
              exact text
              adults
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            2. context exact
              t of relapsed or refractory CD33-positive AML in adults and pediatric patients 2 years and older ( 1.2 ).
              kind
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              polarity
              not_inferred
              span
              end
              327
              end exclusive
              true
              exact text
              pediatric patients
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            3. context exact
              fractory CD33-positive AML in adults and pediatric patients 2 years and older ( 1.2 ).
              kind
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              end exclusive
              true
              exact text
              2 years and older
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            4. context exact
              • treatment of relapsed or refractory CD33-positive AML in adults and pediatric patients 2 years and older ( 1.2 ).
              kind
              biomarker
              polarity
              not_inferred
              span
              end
              321
              end exclusive
              true
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                        Preserved source evidence · Not medical advice