Skip to content
Triangle logo TriangleGet started
← Back to this collection

LABELS · 2d06b03c-17aa-0492-e063-6294a90abd8f

GRAFAPEX

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
2025-01-31
Captured
2026-09-09T23:37:42.544548+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: MYELOSUPPRESSION GRAFAPEX causes severe and prolonged myelosuppression at the recommended dosage. Hematopoietic stem cell transplantation is required to prevent potentially fatal complications of the prolonged myelosuppression. Monitor hematologic laboratory parameters [see Warnings and Precautions ( 5.1 )] . WARNING: MYELOSUPPRESSION See full prescribing information for complete boxed warning. GRAFAPEX causes severe and prolonged myelosuppression. Hematopoietic stem cell transplantation is required to prevent potentially fatal complications of the prolonged myelosuppression. Monitor hematologic laboratory parameters. ( 5.1 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE GRAFAPEX is an alkylating drug indicated for: Use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult and pediatric patients 1 year of age and older with acute myeloid leukemia (AML). ( 1.1 ). Use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age and older with myelodysplastic syndrome (MDS). ( 1.2 ). 1.1 Acute Myeloid Leukemia GRAFAPEX is indicated in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age and older with acute myeloid leukemia (AML). 1.2 Myelodysplastic Syndrome GRAFAPEX is indicated in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age and older with myelodysplastic syndrome (MDS).
Full extracted label fields
application numbers
  1. NDA214759
boxed warning exact
  1. WARNING: MYELOSUPPRESSION GRAFAPEX causes severe and prolonged myelosuppression at the recommended dosage. Hematopoietic stem cell transplantation is required to prevent potentially fatal complications of the prolonged myelosuppression. Monitor hematologic laboratory parameters [see Warnings and Precautions ( 5.1 )] . WARNING: MYELOSUPPRESSION See full prescribing information for complete boxed warning. GRAFAPEX causes severe and prolonged myelosuppression. Hematopoietic stem cell transplantation is required to prevent potentially fatal complications of the prolonged myelosuppression. Monitor hematologic laboratory parameters. ( 5.1 )
brand names
  1. GRAFAPEX
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2d06b03c-17aa-0492-e063-6294a90abd8f
generic names
  1. TREOSULFAN
id
2d06b03c-17aa-0492-e063-6294a90abd8f
indications and usage exact
  1. 1 INDICATIONS AND USAGE GRAFAPEX is an alkylating drug indicated for: Use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult and pediatric patients 1 year of age and older with acute myeloid leukemia (AML). ( 1.1 ). Use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age and older with myelodysplastic syndrome (MDS). ( 1.2 ). 1.1 Acute Myeloid Leukemia GRAFAPEX is indicated in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age and older with acute myeloid leukemia (AML). 1.2 Myelodysplastic Syndrome GRAFAPEX is indicated in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age and older with myelodysplastic syndrome (MDS).
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Medexus Pharma, Inc.
    matched search terms
    1. leukemia
    2. myelodysplastic
    package ndcs
    1. 59137-335-01
    2. 59137-365-01
    product ndcs
    1. 59137-335
    2. 59137-365
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
      record type
      complete_spl_indications_section_candidate
      routes
      1. INTRAVENOUS
      rxcuis
      1. 2703570
      2. 2703575
      3. 2703577
      4. 2703579
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00100.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
      100
      total
      830
      sha256
      fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
      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=100&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%222d06b03c-17aa-0492-e063-6294a90abd8f%22
      spl effective date
      2025-01-31
      spl effective time
      20250131
      spl set id
      2d06b03c-17aa-0492-e063-6294a90abd8f
      spl version
      1
      substance names
      1. TREOSULFAN
      uniis
      1. CO61ER3EPI
      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
      4. fda_label_posted_after_spl_effective_date_requires_version_review
      Drugs@FDA application source records
      1. application number
        NDA214759
        payload
        all indexed label documents
        1. Appl No
          214759
          Application Docs Date
          2025-02-04 00:00:00
          Application Docs ID
          80915
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          214759
          Application Docs Date
          2025-02-07 00:00:00
          Application Docs ID
          81121
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          214759
          Review Priority
          STANDARD
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2025-01-21 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          214759
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2025-02-05 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA214759
        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
        2025-02-05
        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
          214759
          Application Docs Date
          2025-02-07 00:00:00
          Application Docs ID
          81121
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          SUPPL
        official application record
        Appl No
        214759
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        MEDEXUS
        openfda application present
        true
        products
        1. Active Ingredient
          TREOSULFAN
          Appl No
          214759
          Drug Name
          GRAFAPEX
          Form
          POWDER;INTRAVENOUS
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
          Strength
          1GM/VIAL
          marketing status
          1. Prescription
        2. Active Ingredient
          TREOSULFAN
          Appl No
          214759
          Drug Name
          GRAFAPEX
          Form
          POWDER;INTRAVENOUS
          Product No
          002
          Reference Drug
          1
          Reference Standard
          1
          Strength
          5GM/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. NDA214759
      brand names
      1. GRAFAPEX
      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
      487
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE GRAFAPEX is an alkylating drug indicated for: Use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult and pediatric patients 1 year of age and older with acute myeloid leukemia (AML). ( 1.1 ). Use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age and older with myelodysplast
      label id
      2d06b03c-17aa-0492-e063-6294a90abd8f
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      5dd1798cb78d4a665ac1b91fac950286199e0e1d68af288765f2b29cffd8a6fe
      start
      0
      current approval status
      not_reconciled
      duplicate text group
      dup-865489e1ff307ae2376d
      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. TREOSULFAN
      id
      ind-span-b7487799fc0c952ad139
      label id
      2d06b03c-17aa-0492-e063-6294a90abd8f
      positive predicate support span
      end
      64
      end exclusive
      true
      exact text
      is an alkylating drug indicated
      label id
      2d06b03c-17aa-0492-e063-6294a90abd8f
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      5dd1798cb78d4a665ac1b91fac950286199e0e1d68af288765f2b29cffd8a6fe
      start
      33
      qualifier mentions
      1. context exact
        eneic hematopoietic stem cell transplantation (alloHSCT) in adult and pediatric patients 1 year of age and older with acute m
        kind
        age
        polarity
        not_inferred
        span
        end
        205
        end exclusive
        true
        exact text
        adult
        label id
        2d06b03c-17aa-0492-e063-6294a90abd8f
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        5dd1798cb78d4a665ac1b91fac950286199e0e1d68af288765f2b29cffd8a6fe
        start
        200
      2. context exact
        topoietic stem cell transplantation (alloHSCT) in adult and pediatric patients 1 year of age and older with acute myeloid leukemia (AML).
        kind
        age
        polarity
        not_inferred
        span
        end
        228
        end exclusive
        true
        exact text
        pediatric patients
        label id
        2d06b03c-17aa-0492-e063-6294a90abd8f
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        5dd1798cb78d4a665ac1b91fac950286199e0e1d68af288765f2b29cffd8a6fe
        start
        210
      3. context exact
        1 INDICATIONS AND USAGE GRAFAPEX is an alkylating drug indicated for: Use in combination with fludarabine as a preparative regimen for allogen
        kind
        biomarker
        polarity
        not_inferred
        span
        end
        82
        end exclusive
        true
        exact text
        alkylating drug indicated for: Use in combi
        label id
        2d06b03c-17aa-0492-e063-6294a90abd8f
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        5dd1798cb78d4a665ac1b91fac950286199e0e1d68af288765f2b29cffd8a6fe
        start
        39
      4. context exact
        AND USAGE GRAFAPEX is an alkylating drug indicated for: Use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult and pediatric patients 1 year of age and older with acute myeloid leukemia (AML).
        kind
        regimen
        polarity
        not_inferred
        span
        end
        253
        end exclusive
        true
        exact text
        in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult and pediatric patients 1 year of age and older
        label id
        2d06b03c-17aa-0492-e063-6294a90abd8f
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        5dd1798cb78d4a665ac1b91fac950286199e0e1d68af288765f2b29cffd8a6fe
        start
        74
      regulatory links
        schema version
        0.1.0
        source batch sha256
        fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
        source defined aliases
          source span
          end
          287
          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE GRAFAPEX is an alkylating drug indicated for: Use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult and pediatric patients 1 year of age and older with acute myeloid leukemia (AML).
          label id
          2d06b03c-17aa-0492-e063-6294a90abd8f
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          5dd1798cb78d4a665ac1b91fac950286199e0e1d68af288765f2b29cffd8a6fe
          start
          0
          source url
          https://api.fda.gov/drug/label.json?search=id%3A%222d06b03c-17aa-0492-e063-6294a90abd8f%22
          spl effective date
          2025-01-31
          spl set id
          2d06b03c-17aa-0492-e063-6294a90abd8f
          spl version
          1
          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
          Passage 2 · unclassified context
          application numbers
          1. NDA214759
          brand names
          1. GRAFAPEX
          classification reasons
          1. no_unambiguous_positive_indication_predicate
          clinical review status
          pending
          content role
          unclassified_context
          context span
          end
          496
          end exclusive
          true
          exact text
          with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult and pediatric patients 1 year of age and older with acute myeloid leukemia (AML). ( 1.1 ). Use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age and older with myelodysplastic syndro
          label id
          2d06b03c-17aa-0492-e063-6294a90abd8f
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          5dd1798cb78d4a665ac1b91fac950286199e0e1d68af288765f2b29cffd8a6fe
          start
          88
          current approval status
          not_reconciled
          duplicate text group
          dup-4c19064128177459668a
          extraction review status
          automated_candidate_pending_source_review
          generic names
          1. TREOSULFAN
          id
          ind-span-b9ba4be2770ad9be7dbd
          label id
          2d06b03c-17aa-0492-e063-6294a90abd8f
          positive predicate support span
          Source null
          qualifier mentions
            regulatory links
              schema version
              0.1.0
              source batch sha256
              fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
              source defined aliases
                source span
                end
                296
                end exclusive
                true
                exact text
                ( 1.1 ).
                label id
                2d06b03c-17aa-0492-e063-6294a90abd8f
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                5dd1798cb78d4a665ac1b91fac950286199e0e1d68af288765f2b29cffd8a6fe
                start
                288
                source url
                https://api.fda.gov/drug/label.json?search=id%3A%222d06b03c-17aa-0492-e063-6294a90abd8f%22
                spl effective date
                2025-01-31
                spl set id
                2d06b03c-17aa-0492-e063-6294a90abd8f
                spl version
                1
                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
                unclear
                Passage 3 · positive indication candidate
                application numbers
                1. NDA214759
                brand names
                1. GRAFAPEX
                classification reasons
                1. inherited_predicate_from_same_label_section_requires_review
                2. tumor_or_malignant_hematology_words_in_positive_statement
                clinical review status
                pending
                content role
                positive_indication_candidate
                context span
                end
                705
                end exclusive
                true
                exact text
                darabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult and pediatric patients 1 year of age and older with acute myeloid leukemia (AML). ( 1.1 ). Use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age and older with myelodysplastic syndrome (MDS). ( 1.2 ). 1.1 Acute Myeloid Leukemia GRAFAPEX is indicated in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patien
                label id
                2d06b03c-17aa-0492-e063-6294a90abd8f
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                5dd1798cb78d4a665ac1b91fac950286199e0e1d68af288765f2b29cffd8a6fe
                start
                97
                current approval status
                not_reconciled
                duplicate text group
                dup-06ff156da2fdf9208511
                extraction review status
                automated_candidate_pending_source_review
                generic names
                1. TREOSULFAN
                id
                ind-span-3968d0f3b943afc0b2b8
                label id
                2d06b03c-17aa-0492-e063-6294a90abd8f
                positive predicate support span
                end
                64
                end exclusive
                true
                exact text
                is an alkylating drug indicated
                label id
                2d06b03c-17aa-0492-e063-6294a90abd8f
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                5dd1798cb78d4a665ac1b91fac950286199e0e1d68af288765f2b29cffd8a6fe
                start
                33
                qualifier mentions
                1. context exact
                  n for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age and older with myelody
                  kind
                  age
                  polarity
                  not_inferred
                  span
                  end
                  421
                  end exclusive
                  true
                  exact text
                  adult
                  label id
                  2d06b03c-17aa-0492-e063-6294a90abd8f
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  5dd1798cb78d4a665ac1b91fac950286199e0e1d68af288765f2b29cffd8a6fe
                  start
                  416
                2. context exact
                  geneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age and older with myelodysplastic syndrome (MDS)
                  kind
                  age
                  polarity
                  not_inferred
                  span
                  end
                  444
                  end exclusive
                  true
                  exact text
                  pediatric patients
                  label id
                  2d06b03c-17aa-0492-e063-6294a90abd8f
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  5dd1798cb78d4a665ac1b91fac950286199e0e1d68af288765f2b29cffd8a6fe
                  start
                  426
                3. context exact
                  Use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age and older with myelodysplastic syndrome (MDS).
                  kind
                  regimen
                  polarity
                  not_inferred
                  span
                  end
                  480
                  end exclusive
                  true
                  exact text
                  in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age and older with myelod
                  label id
                  2d06b03c-17aa-0492-e063-6294a90abd8f
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  5dd1798cb78d4a665ac1b91fac950286199e0e1d68af288765f2b29cffd8a6fe
                  start
                  301
                regulatory links
                  schema version
                  0.1.0
                  source batch sha256
                  fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                  source defined aliases
                    source span
                    end
                    505
                    end exclusive
                    true
                    exact text
                    Use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age and older with myelodysplastic syndrome (MDS).
                    label id
                    2d06b03c-17aa-0492-e063-6294a90abd8f
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    5dd1798cb78d4a665ac1b91fac950286199e0e1d68af288765f2b29cffd8a6fe
                    start
                    297
                    source url
                    https://api.fda.gov/drug/label.json?search=id%3A%222d06b03c-17aa-0492-e063-6294a90abd8f%22
                    spl effective date
                    2025-01-31
                    spl set id
                    2d06b03c-17aa-0492-e063-6294a90abd8f
                    spl version
                    1
                    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
                    Passage 4 · unclassified context
                    application numbers
                    1. NDA214759
                    brand names
                    1. GRAFAPEX
                    classification reasons
                    1. no_unambiguous_positive_indication_predicate
                    clinical review status
                    pending
                    content role
                    unclassified_context
                    context span
                    end
                    714
                    end exclusive
                    true
                    exact text
                    mbination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age and older with myelodysplastic syndrome (MDS). ( 1.2 ). 1.1 Acute Myeloid Leukemia GRAFAPEX is indicated in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year
                    label id
                    2d06b03c-17aa-0492-e063-6294a90abd8f
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    5dd1798cb78d4a665ac1b91fac950286199e0e1d68af288765f2b29cffd8a6fe
                    start
                    306
                    current approval status
                    not_reconciled
                    duplicate text group
                    dup-e55376af371a8ceb6404
                    extraction review status
                    automated_candidate_pending_source_review
                    generic names
                    1. TREOSULFAN
                    id
                    ind-span-c86e1e56dad812b8d828
                    label id
                    2d06b03c-17aa-0492-e063-6294a90abd8f
                    positive predicate support span
                    Source null
                    qualifier mentions
                      regulatory links
                        schema version
                        0.1.0
                        source batch sha256
                        fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                        source defined aliases
                          source span
                          end
                          514
                          end exclusive
                          true
                          exact text
                          ( 1.2 ).
                          label id
                          2d06b03c-17aa-0492-e063-6294a90abd8f
                          offset unit
                          unicode_code_points
                          source array index
                          0
                          source field
                          indications_and_usage_exact
                          source text sha256
                          5dd1798cb78d4a665ac1b91fac950286199e0e1d68af288765f2b29cffd8a6fe
                          start
                          506
                          source url
                          https://api.fda.gov/drug/label.json?search=id%3A%222d06b03c-17aa-0492-e063-6294a90abd8f%22
                          spl effective date
                          2025-01-31
                          spl set id
                          2d06b03c-17aa-0492-e063-6294a90abd8f
                          spl version
                          1
                          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
                          unclear
                          Passage 5 · positive indication candidate
                          application numbers
                          1. NDA214759
                          brand names
                          1. GRAFAPEX
                          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
                          966
                          end exclusive
                          true
                          exact text
                          with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age and older with myelodysplastic syndrome (MDS). ( 1.2 ). 1.1 Acute Myeloid Leukemia GRAFAPEX is indicated in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age and older with acute myeloid leukemia (AML). 1.2 Myelodysplastic Syndrome GRAFAPEX is indicated in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 ye
                          label id
                          2d06b03c-17aa-0492-e063-6294a90abd8f
                          offset unit
                          unicode_code_points
                          source array index
                          0
                          source field
                          indications_and_usage_exact
                          source text sha256
                          5dd1798cb78d4a665ac1b91fac950286199e0e1d68af288765f2b29cffd8a6fe
                          start
                          315
                          current approval status
                          not_reconciled
                          duplicate text group
                          dup-955a5e021f033d470f50
                          extraction review status
                          automated_candidate_pending_source_review
                          generic names
                          1. TREOSULFAN
                          id
                          ind-span-248145361c4dc89bde3e
                          label id
                          2d06b03c-17aa-0492-e063-6294a90abd8f
                          positive predicate support span
                          end
                          563
                          end exclusive
                          true
                          exact text
                          is indicated
                          label id
                          2d06b03c-17aa-0492-e063-6294a90abd8f
                          offset unit
                          unicode_code_points
                          source array index
                          0
                          source field
                          indications_and_usage_exact
                          source text sha256
                          5dd1798cb78d4a665ac1b91fac950286199e0e1d68af288765f2b29cffd8a6fe
                          start
                          551
                          qualifier mentions
                          1. context exact
                            n for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age and older with acute m
                            kind
                            age
                            polarity
                            not_inferred
                            span
                            end
                            684
                            end exclusive
                            true
                            exact text
                            adult
                            label id
                            2d06b03c-17aa-0492-e063-6294a90abd8f
                            offset unit
                            unicode_code_points
                            source array index
                            0
                            source field
                            indications_and_usage_exact
                            source text sha256
                            5dd1798cb78d4a665ac1b91fac950286199e0e1d68af288765f2b29cffd8a6fe
                            start
                            679
                          2. context exact
                            geneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age and older with acute myeloid leukemia (AML).
                            kind
                            age
                            polarity
                            not_inferred
                            span
                            end
                            707
                            end exclusive
                            true
                            exact text
                            pediatric patients
                            label id
                            2d06b03c-17aa-0492-e063-6294a90abd8f
                            offset unit
                            unicode_code_points
                            source array index
                            0
                            source field
                            indications_and_usage_exact
                            source text sha256
                            5dd1798cb78d4a665ac1b91fac950286199e0e1d68af288765f2b29cffd8a6fe
                            start
                            689
                          3. context exact
                            1.1 Acute Myeloid Leukemia GRAFAPEX is indicated in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age and older with acute myeloid leukemia (AML).
                            kind
                            regimen
                            polarity
                            not_inferred
                            span
                            end
                            743
                            end exclusive
                            true
                            exact text
                            in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age and older with acute
                            label id
                            2d06b03c-17aa-0492-e063-6294a90abd8f
                            offset unit
                            unicode_code_points
                            source array index
                            0
                            source field
                            indications_and_usage_exact
                            source text sha256
                            5dd1798cb78d4a665ac1b91fac950286199e0e1d68af288765f2b29cffd8a6fe
                            start
                            564
                          regulatory links
                            schema version
                            0.1.0
                            source batch sha256
                            fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                            source defined aliases
                              source span
                              end
                              766
                              end exclusive
                              true
                              exact text
                              1.1 Acute Myeloid Leukemia GRAFAPEX is indicated in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age and older with acute myeloid leukemia (AML).
                              label id
                              2d06b03c-17aa-0492-e063-6294a90abd8f
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              5dd1798cb78d4a665ac1b91fac950286199e0e1d68af288765f2b29cffd8a6fe
                              start
                              515
                              source url
                              https://api.fda.gov/drug/label.json?search=id%3A%222d06b03c-17aa-0492-e063-6294a90abd8f%22
                              spl effective date
                              2025-01-31
                              spl set id
                              2d06b03c-17aa-0492-e063-6294a90abd8f
                              spl version
                              1
                              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
                              Passage 6 · positive indication candidate
                              application numbers
                              1. NDA214759
                              brand names
                              1. GRAFAPEX
                              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
                              1022
                              end exclusive
                              true
                              exact text
                              combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age and older with acute myeloid leukemia (AML). 1.2 Myelodysplastic Syndrome GRAFAPEX is indicated in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age and older with myelodysplastic syndrome (MDS).
                              label id
                              2d06b03c-17aa-0492-e063-6294a90abd8f
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              5dd1798cb78d4a665ac1b91fac950286199e0e1d68af288765f2b29cffd8a6fe
                              start
                              567
                              current approval status
                              not_reconciled
                              duplicate text group
                              dup-5c3313f0c390909af7fe
                              extraction review status
                              automated_candidate_pending_source_review
                              generic names
                              1. TREOSULFAN
                              id
                              ind-span-d7020ab63d129c2ae47e
                              label id
                              2d06b03c-17aa-0492-e063-6294a90abd8f
                              positive predicate support span
                              end
                              817
                              end exclusive
                              true
                              exact text
                              is indicated
                              label id
                              2d06b03c-17aa-0492-e063-6294a90abd8f
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              5dd1798cb78d4a665ac1b91fac950286199e0e1d68af288765f2b29cffd8a6fe
                              start
                              805
                              qualifier mentions
                              1. context exact
                                n for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age and older with myelody
                                kind
                                age
                                polarity
                                not_inferred
                                span
                                end
                                938
                                end exclusive
                                true
                                exact text
                                adult
                                label id
                                2d06b03c-17aa-0492-e063-6294a90abd8f
                                offset unit
                                unicode_code_points
                                source array index
                                0
                                source field
                                indications_and_usage_exact
                                source text sha256
                                5dd1798cb78d4a665ac1b91fac950286199e0e1d68af288765f2b29cffd8a6fe
                                start
                                933
                              2. context exact
                                geneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age and older with myelodysplastic syndrome (MDS)
                                kind
                                age
                                polarity
                                not_inferred
                                span
                                end
                                961
                                end exclusive
                                true
                                exact text
                                pediatric patients
                                label id
                                2d06b03c-17aa-0492-e063-6294a90abd8f
                                offset unit
                                unicode_code_points
                                source array index
                                0
                                source field
                                indications_and_usage_exact
                                source text sha256
                                5dd1798cb78d4a665ac1b91fac950286199e0e1d68af288765f2b29cffd8a6fe
                                start
                                943
                              3. context exact
                                1.2 Myelodysplastic Syndrome GRAFAPEX is indicated in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age and older with myelodysplastic syndrome (MDS).
                                kind
                                regimen
                                polarity
                                not_inferred
                                span
                                end
                                997
                                end exclusive
                                true
                                exact text
                                in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age and older with myelod
                                label id
                                2d06b03c-17aa-0492-e063-6294a90abd8f
                                offset unit
                                unicode_code_points
                                source array index
                                0
                                source field
                                indications_and_usage_exact
                                source text sha256
                                5dd1798cb78d4a665ac1b91fac950286199e0e1d68af288765f2b29cffd8a6fe
                                start
                                818
                              regulatory links
                                schema version
                                0.1.0
                                source batch sha256
                                fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                source defined aliases
                                  source span
                                  end
                                  1022
                                  end exclusive
                                  true
                                  exact text
                                  1.2 Myelodysplastic Syndrome GRAFAPEX is indicated in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age and older with myelodysplastic syndrome (MDS).
                                  label id
                                  2d06b03c-17aa-0492-e063-6294a90abd8f
                                  offset unit
                                  unicode_code_points
                                  source array index
                                  0
                                  source field
                                  indications_and_usage_exact
                                  source text sha256
                                  5dd1798cb78d4a665ac1b91fac950286199e0e1d68af288765f2b29cffd8a6fe
                                  start
                                  767
                                  source url
                                  https://api.fda.gov/drug/label.json?search=id%3A%222d06b03c-17aa-0492-e063-6294a90abd8f%22
                                  spl effective date
                                  2025-01-31
                                  spl set id
                                  2d06b03c-17aa-0492-e063-6294a90abd8f
                                  spl version
                                  1
                                  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