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LABELS · 24f87fb8-dc5d-4daf-8afc-047afe1bcfee

VIVIMUSTA

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
2025-04-03
Captured
2026-09-09T23:37:42.544548+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS & USAGE VIVIMUSTA is an alkylating drug indicated for treatment of patients with: • Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. ( 1.1 ) • Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. ( 1.2 ) 1.1 Chronic Lymphocytic Leukemia (CLL) VIVIMUSTA is indicated for the treatment of adult patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established. 1.2 Non-Hodgkin Lymphoma (NHL) VIVIMUSTA is indicated for the treatment of adult patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.
Full extracted label fields
application numbers
  1. NDA212209
boxed warning exact
    brand names
    1. VIVIMUSTA
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4df6548f-c4ad-4eb2-a54f-19766a3d90ca
    generic names
    1. BENDAMUSTINE HYDROCHLORIDE
    id
    24f87fb8-dc5d-4daf-8afc-047afe1bcfee
    indications and usage exact
    1. 1 INDICATIONS & USAGE VIVIMUSTA is an alkylating drug indicated for treatment of patients with: • Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. ( 1.1 ) • Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. ( 1.2 ) 1.1 Chronic Lymphocytic Leukemia (CLL) VIVIMUSTA is indicated for the treatment of adult patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established. 1.2 Non-Hodgkin Lymphoma (NHL) VIVIMUSTA is indicated for the treatment of adult patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Azurity Pharmaceuticals, Inc.
      matched search terms
      1. lymphoma
      2. leukemia
      package ndcs
      1. 24338-270-01
      product ndcs
      1. 24338-270
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. INTRAVENOUS
        rxcuis
        1. 1726097
        2. 2622914
        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
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        skip
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        total
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        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
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        spl set id
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        spl version
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        substance names
        1. BENDAMUSTINE HYDROCHLORIDE
        uniis
        1. 981Y8SX18M
        verification flags
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        2. spl_text_not_verified_identical_to_latest_approved_label
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        Drugs@FDA application source records
        1. application number
          NDA212209
          payload
          all indexed label documents
          1. Appl No
            212209
            Application Docs Date
            2022-12-09 00:00:00
            Application Docs ID
            72834
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
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          2. Appl No
            212209
            Application Docs Date
            2024-02-12 00:00:00
            Application Docs ID
            77478
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            4
            Submission Type
            SUPPL
          3. Appl No
            212209
            Application Docs Date
            2024-02-28 00:00:00
            Application Docs ID
            77640
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            5
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            212209
            Review Priority
            STANDARD
            Submission Class Code ID
            15
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2022-12-07 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            212209
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            3
            Submission Status
            AP
            Submission Status Date
            2023-05-15 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            212209
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            4
            Submission Status
            AP
            Submission Status Date
            2024-02-08 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            212209
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            5
            Submission Status
            AP
            Submission Status Date
            2024-02-27 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA212209
          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
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          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
            212209
            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
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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
          AZURITY
          openfda application present
          true
          products
          1. Active Ingredient
            BENDAMUSTINE HYDROCHLORIDE
            Appl No
            212209
            Drug Name
            VIVIMUSTA
            Form
            SOLUTION;INTRAVENOUS
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            Strength
            100MG/4ML (25MG/ML)
            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. NDA212209
        brand names
        1. VIVIMUSTA
        classification reasons
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        2. no_tumor_directed_keyword_in_positive_statement
        clinical review status
        pending
        content role
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        context span
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        295
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        true
        exact text
        1 INDICATIONS & USAGE VIVIMUSTA is an alkylating drug indicated for treatment of patients with: • Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. ( 1.1 ) • Indolent B-cell non-Hodgkin lymphoma (NHL) that has progres
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        is an alkylating drug indicated
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        qualifier mentions
        1. context exact
          1 INDICATIONS & USAGE VIVIMUSTA is an alkylating drug indicated for treatment of patients with:
          kind
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            1 INDICATIONS & USAGE VIVIMUSTA is an alkylating drug indicated for treatment of patients with:
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            1 INDICATIONS & USAGE VIVIMUSTA is an alkylating drug indicated for treatment of patients with: • Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. ( 1.1 ) • Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of tre
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                  • Chronic lymphocytic leukemia (CLL).
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                  1 INDICATIONS & USAGE VIVIMUSTA is an alkylating drug indicated for treatment of patients with: • Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. ( 1.1 ) • Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. ( 1.2 ) 1.1 Chronic Lymphocytic Leu
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                      MUSTA is an alkylating drug indicated for treatment of patients with: • Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. ( 1.1 ) • Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. ( 1.2 ) 1.1 Chronic Lymphocytic Leukemia (C
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                            an alkylating drug indicated for treatment of patients with: • Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. ( 1.1 ) • Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. ( 1.2 ) 1.1 Chronic Lymphocytic Leukemia (CLL) VIVIMUSTA is indicated for the treatment of adult patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlor
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                                                    Preserved source evidence · Not medical advice