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LABELS · da6a0ae8-6165-4e4f-b759-600cd940d252

MYLERAN

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
2025-01-08
Captured
2026-09-09T23:38:02.384588+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING MYLERAN is a potent drug. It should not be used unless a diagnosis of chronic myelogenous leukemia has been adequately established and the responsible physician is knowledgeable in assessing response to chemotherapy. MYLERAN can induce severe bone marrow hypoplasia. Reduce or discontinue the dosage immediately at the first sign of any unusual depression of bone marrow function as reflected by an abnormal decrease in any of the formed elements of the blood. A bone marrow examination should be performed if the bone marrow status is uncertain. SEE WARNINGS FOR INFORMATION REGARDING BUSULFAN-INDUCED LEUKEMOGENESIS IN HUMANS.

Indications and usage: exact source text

  1. INDICATIONS AND USAGE MYLERAN (busulfan) is indicated for the palliative treatment of chronic myelogenous (myeloid, myelocytic, granulocytic) leukemia.
Full extracted label fields
application numbers
  1. NDA009386
boxed warning exact
  1. WARNING MYLERAN is a potent drug. It should not be used unless a diagnosis of chronic myelogenous leukemia has been adequately established and the responsible physician is knowledgeable in assessing response to chemotherapy. MYLERAN can induce severe bone marrow hypoplasia. Reduce or discontinue the dosage immediately at the first sign of any unusual depression of bone marrow function as reflected by an abnormal decrease in any of the formed elements of the blood. A bone marrow examination should be performed if the bone marrow status is uncertain. SEE WARNINGS FOR INFORMATION REGARDING BUSULFAN-INDUCED LEUKEMOGENESIS IN HUMANS.
brand names
  1. MYLERAN
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2da33e5b-dcfb-4cdf-b163-50398e42f41c
generic names
  1. BUSULFAN
id
da6a0ae8-6165-4e4f-b759-600cd940d252
indications and usage exact
  1. INDICATIONS AND USAGE MYLERAN (busulfan) is indicated for the palliative treatment of chronic myelogenous (myeloid, myelocytic, granulocytic) leukemia.
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Waylis Therapeutics LLC
    matched search terms
    1. leukemia
    package ndcs
    1. 80725-620-25
    product ndcs
    1. 80725-620
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
      1. 105551
      2. 197422
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00700.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
      700
      total
      830
      sha256
      24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
      url
      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=700&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%22da6a0ae8-6165-4e4f-b759-600cd940d252%22
      spl effective date
      2025-01-08
      spl effective time
      20250108
      spl set id
      2da33e5b-dcfb-4cdf-b163-50398e42f41c
      spl version
      2
      substance names
      1. BUSULFAN
      uniis
      1. G1LN9045DK
      verification flags
      1. oncology_keyword_candidate_not_clinically_classified
      2. spl_text_not_verified_identical_to_latest_approved_label
      3. individual_indications_not_split_or_reconciled
      Drugs@FDA application source records
      1. application number
        NDA009386
        payload
        all indexed label documents
        1. Appl No
          009386
          Application Docs Date
          2003-03-06 00:00:00
          Application Docs ID
          10727
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          19
          Submission Type
          SUPPL
        2. Appl No
          009386
          Application Docs Date
          2004-01-15 00:00:00
          Application Docs ID
          32998
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          13
          Submission Type
          SUPPL
        3. Appl No
          009386
          Application Docs Date
          2003-04-17 00:00:00
          Application Docs ID
          32999
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          21
          Submission Type
          SUPPL
        4. Appl No
          009386
          Application Docs Date
          2004-02-03 00:00:00
          Application Docs ID
          33000
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          23
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          009386
          Review Priority
          PRIORITY
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          1954-06-26 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          009386
          Review Priority
          PRIORITY
          Submission Class Code ID
          21
          Submission No
          4
          Submission Status
          AP
          Submission Status Date
          1975-11-21 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          009386
          Review Priority
          PRIORITY
          Submission Class Code ID
          4
          Submission No
          5
          Submission Status
          AP
          Submission Status Date
          1977-02-10 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          009386
          Review Priority
          Submission Class Code ID
          3
          Submission No
          6
          Submission Status
          AP
          Submission Status Date
          1979-11-08 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          009386
          Review Priority
          Submission Class Code ID
          3
          Submission No
          7
          Submission Status
          AP
          Submission Status Date
          1981-05-11 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          009386
          Review Priority
          Submission Class Code ID
          3
          Submission No
          8
          Submission Status
          AP
          Submission Status Date
          1986-05-19 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          009386
          Review Priority
          Submission Class Code ID
          3
          Submission No
          9
          Submission Status
          AP
          Submission Status Date
          1987-04-09 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          009386
          Review Priority
          Submission Class Code ID
          3
          Submission No
          10
          Submission Status
          AP
          Submission Status Date
          1987-04-09 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          009386
          Review Priority
          PRIORITY
          Submission Class Code ID
          4
          Submission No
          11
          Submission Status
          AP
          Submission Status Date
          1990-03-20 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        10. Appl No
          009386
          Review Priority
          Submission Class Code ID
          3
          Submission No
          12
          Submission Status
          AP
          Submission Status Date
          1990-09-17 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        11. Appl No
          009386
          Review Priority
          Submission Class Code ID
          3
          Submission No
          13
          Submission Status
          AP
          Submission Status Date
          1991-07-15 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        12. Appl No
          009386
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          15
          Submission Status
          AP
          Submission Status Date
          1994-07-29 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA009386
        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
        2003-12-24
        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
          009386
          Application Docs Date
          2004-02-03 00:00:00
          Application Docs ID
          33000
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          23
          Submission Type
          SUPPL
        official application record
        Appl No
        009386
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        WAYLIS THERAP
        openfda application present
        true
        products
        1. Active Ingredient
          BUSULFAN
          Appl No
          009386
          Drug Name
          MYLERAN
          Form
          TABLET;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
          Strength
          2MG
          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. NDA009386
      brand names
      1. MYLERAN
      classification reasons
      1. explicit_positive_indication_predicate
      2. tumor_or_malignant_hematology_words_in_positive_statement
      clinical review status
      pending
      content role
      positive_indication_candidate
      context span
      end
      151
      end exclusive
      true
      exact text
      INDICATIONS AND USAGE MYLERAN (busulfan) is indicated for the palliative treatment of chronic myelogenous (myeloid, myelocytic, granulocytic) leukemia.
      label id
      da6a0ae8-6165-4e4f-b759-600cd940d252
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      a0a884cf428b146b5318ad4c123fbf2c7d6b2da56269e9c6647bc138ca605b1d
      start
      0
      current approval status
      not_reconciled
      duplicate text group
      dup-928e8dc991c54203d132
      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. BUSULFAN
      id
      ind-span-3528f87c7d84206662c2
      label id
      da6a0ae8-6165-4e4f-b759-600cd940d252
      positive predicate support span
      end
      53
      end exclusive
      true
      exact text
      is indicated
      label id
      da6a0ae8-6165-4e4f-b759-600cd940d252
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      a0a884cf428b146b5318ad4c123fbf2c7d6b2da56269e9c6647bc138ca605b1d
      start
      41
      qualifier mentions
        regulatory links
          schema version
          0.1.0
          source batch sha256
          24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
          source defined aliases
            source span
            end
            151
            end exclusive
            true
            exact text
            INDICATIONS AND USAGE MYLERAN (busulfan) is indicated for the palliative treatment of chronic myelogenous (myeloid, myelocytic, granulocytic) leukemia.
            label id
            da6a0ae8-6165-4e4f-b759-600cd940d252
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            a0a884cf428b146b5318ad4c123fbf2c7d6b2da56269e9c6647bc138ca605b1d
            start
            0
            source url
            https://api.fda.gov/drug/label.json?search=id%3A%22da6a0ae8-6165-4e4f-b759-600cd940d252%22
            spl effective date
            2025-01-08
            spl set id
            2da33e5b-dcfb-4cdf-b163-50398e42f41c
            spl version
            2
            structured fields status
            not_extracted_no_values_inferred_from_mentions
            structured indication
            age
            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
            tumor_directed_candidate

            Preserved source evidence · Not medical advice