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LABELS · 5b900700-64d3-4f68-834a-2a71f5216a46

iwilfin

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
2026-03-26
Captured
2026-09-09T23:37:47.659725+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE IWILFIN (eflornithine) is indicated to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy. IWILFIN is an ornithine decarboxylase inhibitor indicated to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy. ( 1 )
Full extracted label fields
application numbers
  1. NDA215500
boxed warning exact
    brand names
    1. iwilfin
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6716d8cc-66e6-4cee-935c-ccb85ed984f5
    generic names
    1. EFLORNITHINE HYDROCHLORIDE
    id
    5b900700-64d3-4f68-834a-2a71f5216a46
    indications and usage exact
    1. 1 INDICATIONS AND USAGE IWILFIN (eflornithine) is indicated to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy. IWILFIN is an ornithine decarboxylase inhibitor indicated to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy. ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. USWM, LLC
      matched search terms
      1. neuroblastoma
      package ndcs
      1. 78670-150-01
      product ndcs
      1. 78670-150
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Dosage and Administration ( 2.3 ) 11/2024
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
      1. 2673199
      2. 2673205
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00300.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
      300
      total
      830
      sha256
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      url
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      source url
      https://api.fda.gov/drug/label.json?search=id%3A%225b900700-64d3-4f68-834a-2a71f5216a46%22
      spl effective date
      2026-03-26
      spl effective time
      20260326
      spl set id
      6716d8cc-66e6-4cee-935c-ccb85ed984f5
      spl version
      7
      substance names
      1. EFLORNITHINE HYDROCHLORIDE
      uniis
      1. 4NH22NDW9H
      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
        NDA215500
        payload
        all indexed label documents
        1. Appl No
          215500
          Application Docs Date
          2023-12-14 00:00:00
          Application Docs ID
          76822
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          215500
          Application Docs Date
          2024-12-02 00:00:00
          Application Docs ID
          80460
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          215500
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2024-11-26 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        2. Appl No
          215500
          Review Priority
          PRIORITY
          Submission Class Code ID
          15
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2023-12-13 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        application number
        NDA215500
        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
        2024-11-26
        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
          215500
          Application Docs Date
          2024-12-02 00:00:00
          Application Docs ID
          80460
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          SUPPL
        official application record
        Appl No
        215500
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        USWM
        openfda application present
        true
        products
        1. Active Ingredient
          EFLORNITHINE HYDROCHLORIDE
          Appl No
          215500
          Drug Name
          IWILFIN
          Form
          TABLET;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
          Strength
          EQ 192MG BASE
          marketing status
          1. Prescription

      Source passages and status connections

      Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

      Passage 1 · positive indication candidate
      application numbers
      1. NDA215500
      brand names
      1. iwilfin
      classification reasons
      1. explicit_positive_indication_predicate
      2. tumor_or_malignant_hematology_words_in_positive_statement
      3. positive_statement_also_contains_qualification_review_required
      clinical review status
      pending
      content role
      positive_indication_candidate
      context span
      end
      484
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE IWILFIN (eflornithine) is indicated to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy. IWILFIN is an ornithine decarboxylase inhibitor indicated to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial re
      label id
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      source text sha256
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      current approval status
      not_reconciled
      duplicate text group
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      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. EFLORNITHINE HYDROCHLORIDE
      id
      ind-span-04875ceded43cf98a29f
      label id
      5b900700-64d3-4f68-834a-2a71f5216a46
      positive predicate support span
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      true
      exact text
      is indicated
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      source text sha256
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      qualifier mentions
      1. context exact
        eflornithine) is indicated to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB)
        kind
        age
        polarity
        not_inferred
        span
        end
        98
        end exclusive
        true
        exact text
        adult
        label id
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        source text sha256
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      2. context exact
        ne) is indicated to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated a
        kind
        age
        polarity
        not_inferred
        span
        end
        121
        end exclusive
        true
        exact text
        pediatric patients
        label id
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        source field
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        source text sha256
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      regulatory links
        schema version
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          true
          exact text
          1 INDICATIONS AND USAGE IWILFIN (eflornithine) is indicated to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy.
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          start
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          source url
          https://api.fda.gov/drug/label.json?search=id%3A%225b900700-64d3-4f68-834a-2a71f5216a46%22
          spl effective date
          2026-03-26
          spl set id
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          spl version
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          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 · positive indication candidate
          application numbers
          1. NDA215500
          brand names
          1. iwilfin
          classification reasons
          1. explicit_positive_indication_predicate
          2. tumor_or_malignant_hematology_words_in_positive_statement
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          clinical review status
          pending
          content role
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          context span
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          573
          end exclusive
          true
          exact text
          apse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy. IWILFIN is an ornithine decarboxylase inhibitor indicated to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy. ( 1 )
          label id
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          offset unit
          unicode_code_points
          source array index
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          source field
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          source text sha256
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          current approval status
          not_reconciled
          duplicate text group
          dup-2a4eca7363c9275cb1c5
          extraction review status
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          generic names
          1. EFLORNITHINE HYDROCHLORIDE
          id
          ind-span-00dd7dfcf70098fa70d9
          label id
          5b900700-64d3-4f68-834a-2a71f5216a46
          positive predicate support span
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          342
          end exclusive
          true
          exact text
          is an ornithine decarboxylase inhibitor indicated
          label id
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          offset unit
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          source text sha256
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          qualifier mentions
          1. context exact
            xylase inhibitor indicated to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB)
            kind
            age
            polarity
            not_inferred
            span
            end
            381
            end exclusive
            true
            exact text
            adult
            label id
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            source field
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            source text sha256
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          2. context exact
            ibitor indicated to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated a
            kind
            age
            polarity
            not_inferred
            span
            end
            404
            end exclusive
            true
            exact text
            pediatric patients
            label id
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            offset unit
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            source array index
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            source text sha256
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          regulatory links
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            source batch sha256
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            source defined aliases
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              true
              exact text
              IWILFIN is an ornithine decarboxylase inhibitor indicated to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy.
              label id
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              source url
              https://api.fda.gov/drug/label.json?search=id%3A%225b900700-64d3-4f68-834a-2a71f5216a46%22
              spl effective date
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              spl set id
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              spl version
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              structured fields status
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              approval pathway
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              biomarker and test
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              disease stage
              Source null
              limitations
              Source null
              line
              Source null
              prior therapy
              Source null
              regimen
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              tumor histology
              Source null
              use intent
              tumor_directed_candidate
              Passage 3 · unclassified context
              application numbers
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              brand names
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              true
              exact text
              apse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy. ( 1 )
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              label id
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              positive predicate support span
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              qualifier mentions
                regulatory links
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                    ( 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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                    approval pathway
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                    biomarker and test
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                    disease stage
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                    limitations
                    Source null
                    line
                    Source null
                    prior therapy
                    Source null
                    regimen
                    Source null
                    tumor histology
                    Source null
                    use intent
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                    Preserved source evidence · Not medical advice