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LABELS · 0af69daf-c3eb-436a-b8d9-8ae89c5f0c85

Beleodaq

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
2025-04-07
Captured
2026-09-09T23:37:39.774134+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Beleodaq is indicated for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on tumor response rate and duration of response [ see Clinical Studies ( 14 )]. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. Beleodaq is a histone deacetylase inhibitor indicated for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on tumor response rate and duration of response. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.( 1 )
Full extracted label fields
application numbers
  1. NDA206256
boxed warning exact
    brand names
    1. Beleodaq
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2e8ef36b-71fa-4492-a16f-577d5f7d111d
    generic names
    1. BELINOSTAT
    id
    0af69daf-c3eb-436a-b8d9-8ae89c5f0c85
    indications and usage exact
    1. 1 INDICATIONS AND USAGE Beleodaq is indicated for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on tumor response rate and duration of response [ see Clinical Studies ( 14 )]. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. Beleodaq is a histone deacetylase inhibitor indicated for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on tumor response rate and duration of response. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Acrotech Biopharma Inc
      matched search terms
      1. lymphoma
      2. tumor
      package ndcs
      1. 72893-002-01
      product ndcs
      1. 72893-002
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Dosage and Administration ( 2.3 , 2.4 , 2.6 ) 11/2024
      record type
      complete_spl_indications_section_candidate
      routes
      1. INTRAVENOUS
      rxcuis
      1. 1543547
      2. 1543552
      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
      100
      skip
      0
      total
      830
      sha256
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      url
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      source url
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      spl effective date
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      spl effective time
      20250407
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      spl version
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      1. BELINOSTAT
      uniis
      1. F4H96P17NZ
      verification flags
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      1. application number
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        payload
        all indexed label documents
        1. Appl No
          206256
          Application Docs Date
          2014-07-02 00:00:00
          Application Docs ID
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          Application Docs Title
          0
          Application Docs Type ID
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          Submission No
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          Submission Type
          ORIG
        2. Appl No
          206256
          Application Docs Date
          2017-04-13 00:00:00
          Application Docs ID
          48003
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          2
          Submission Type
          SUPPL
        3. Appl No
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          Application Docs Date
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          Application Docs ID
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          Application Docs Title
          0
          Application Docs Type ID
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          Submission No
          3
          Submission Type
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        4. Appl No
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          Application Docs Date
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          Application Docs ID
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          Application Docs Type ID
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          Submission No
          4
          Submission Type
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        5. Appl No
          206256
          Application Docs Date
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          Application Docs ID
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          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          6
          Submission Type
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        all submission records
        1. Appl No
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          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
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          Submission Status
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          Submission Status Date
          2024-11-19 00:00:00
          Submission Type
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          Submissions Public Notes
        2. Appl No
          206256
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          4
          Submission Status
          AP
          Submission Status Date
          2022-04-20 00:00:00
          Submission Type
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          Submissions Public Notes
        3. Appl No
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          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
          3
          Submission Status
          AP
          Submission Status Date
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          Submission Type
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          Submissions Public Notes
        4. Appl No
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          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          2
          Submission Status
          AP
          Submission Status Date
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          Submission Type
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          Submissions Public Notes
        5. Appl No
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          Review Priority
          PRIORITY
          Submission Class Code ID
          4
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
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          Submission Type
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          Submissions Public Notes
        6. Appl No
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          Review Priority
          PRIORITY
          Submission Class Code ID
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          Submission No
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          Submission Status
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          Submission Status Date
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          Submission Type
          ORIG
          Submissions Public Notes
        application number
        NDA206256
        approval interpretation
        Application linkage and approved submission are not indication-level current approval verification
        current indication status
        not_reconciled
        has approved submission record
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        latest approved submission date
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        latest posted label documents
        1. Appl No
          206256
          Application Docs Date
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          Application Docs ID
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          Application Docs Title
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          Application Docs Type ID
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          Submission No
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          Submission Type
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        official application record
        Appl No
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        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        ACROTECH BIOPHARMA
        openfda application present
        true
        products
        1. Active Ingredient
          BELINOSTAT
          Appl No
          206256
          Drug Name
          BELEODAQ
          Form
          POWDER;INTRAVENOUS
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
          Strength
          500MG/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
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      brand names
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      true
      exact text
      1 INDICATIONS AND USAGE Beleodaq is indicated for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on tumor response rate and duration of response [ see Clinical Studies ( 14 )]. An improvement in survival or disease-related symptoms has
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      qualifier mentions
      1. context exact
        ATIONS AND USAGE Beleodaq is indicated for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (PTC
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        adult patients
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      2. context exact
        eodaq is indicated for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
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        relapsed or refractory peripheral T-cell ly
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          1 INDICATIONS AND USAGE Beleodaq is indicated for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
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          spl effective date
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          1 INDICATIONS AND USAGE Beleodaq is indicated for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on tumor response rate and duration of response [ see Clinical Studies ( 14 )]. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the
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                This indication is approved under accelerated approval based on tumor response rate and duration of response [ see Clinical Studies ( 14 )].
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                relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on tumor response rate and duration of response [ see Clinical Studies ( 14 )]. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. Beleodaq is a histone deacetylase inhibitor indicated for the
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                      roved under accelerated approval based on tumor response rate and duration of response [ see Clinical Studies ( 14 )]. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. Beleodaq is a histone deacetylase inhibitor indicated for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated
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                                                  Preserved source evidence · Not medical advice