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LABELS · 6fb2ce70-c98f-4e46-9b0f-6aec0530f61d

BORUZU

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
2025-07-05
Captured
2026-09-09T23:37:51.659493+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE BORUZU is a proteasome inhibitor indicated for: treatment of adult patients with multiple myeloma ( 1.1 ) treatment of adult patients with mantle cell lymphoma ( 1.2 ) 1.1 Multiple Myeloma BORUZU is indicated for the treatment of adult patients with multiple myeloma. 1.2 Mantle Cell Lymphoma BORUZU is indicated for the treatment of adult patients with mantle cell lymphoma.
Full extracted label fields
application numbers
  1. NDA212782
boxed warning exact
    brand names
    1. BORUZU
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b92628dd-fa09-4c3a-b6a3-66426025807c
    generic names
    1. BORTEZOMIB
    id
    6fb2ce70-c98f-4e46-9b0f-6aec0530f61d
    indications and usage exact
    1. 1 INDICATIONS AND USAGE BORUZU is a proteasome inhibitor indicated for: treatment of adult patients with multiple myeloma ( 1.1 ) treatment of adult patients with mantle cell lymphoma ( 1.2 ) 1.1 Multiple Myeloma BORUZU is indicated for the treatment of adult patients with multiple myeloma. 1.2 Mantle Cell Lymphoma BORUZU is indicated for the treatment of adult patients with mantle cell lymphoma.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Amneal Pharmaceuticals LLC
      matched search terms
      1. lymphoma
      2. myeloma
      package ndcs
      1. 70121-2484-1
      product ndcs
      1. 70121-2484
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. INTRAVENOUS
        2. SUBCUTANEOUS
        rxcuis
        1. 2608948
        2. 2693996
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00400.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
        400
        total
        830
        sha256
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        url
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        source url
        https://api.fda.gov/drug/label.json?search=id%3A%226fb2ce70-c98f-4e46-9b0f-6aec0530f61d%22
        spl effective date
        2025-07-05
        spl effective time
        20250705
        spl set id
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        spl version
        2
        substance names
        1. BORTEZOMIB
        uniis
        1. 69G8BD63PP
        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
          NDA212782
          payload
          all indexed label documents
          1. Appl No
            212782
            Application Docs Date
            2024-08-29 00:00:00
            Application Docs ID
            79496
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          all submission records
          1. Appl No
            212782
            Review Priority
            STANDARD
            Submission Class Code ID
            15
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2024-08-26 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          application number
          NDA212782
          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
          2024-08-26
          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
            212782
            Application Docs Date
            2024-08-29 00:00:00
            Application Docs ID
            79496
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          official application record
          Appl No
          212782
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          SHILPA
          openfda application present
          true
          products
          1. Active Ingredient
            BORTEZOMIB
            Appl No
            212782
            Drug Name
            BORTEZOMIB
            Form
            SOLUTION;INTRAVENOUS, SUBCUTANEOUS
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            Strength
            3.5MG/1.4ML (2.5MG/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. NDA212782
        brand names
        1. BORUZU
        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
        391
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE BORUZU is a proteasome inhibitor indicated for: treatment of adult patients with multiple myeloma ( 1.1 ) treatment of adult patients with mantle cell lymphoma ( 1.2 ) 1.1 Multiple Myeloma BORUZU is indicated for the treatment of adult patients with multiple myeloma. 1.2 Mantle Cell Lymphoma BORUZU is indicated for the treatment of adult patients with mantle cell l
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        current approval status
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        duplicate text group
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        extraction review status
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        generic names
        1. BORTEZOMIB
        id
        ind-span-e0050bf74a282f4a73bd
        label id
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        positive predicate support span
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        end exclusive
        true
        exact text
        is a proteasome inhibitor indicated
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        source text sha256
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        qualifier mentions
        1. context exact
          ORUZU is a proteasome inhibitor indicated for: treatment of adult patients with multiple myeloma ( 1.1 ) treatment of adult patients w
          kind
          age
          polarity
          not_inferred
          span
          end
          99
          end exclusive
          true
          exact text
          adult patients
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          source text sha256
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        2. context exact
          f adult patients with multiple myeloma ( 1.1 ) treatment of adult patients with mantle cell lymphoma ( 1.2 )
          kind
          age
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          not_inferred
          span
          end
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        regulatory links
          schema version
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            exact text
            1 INDICATIONS AND USAGE BORUZU is a proteasome inhibitor indicated for: treatment of adult patients with multiple myeloma ( 1.1 ) treatment of adult patients with mantle cell lymphoma ( 1.2 )
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            source url
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            spl effective date
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            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. NDA212782
            brand names
            1. BORUZU
            classification reasons
            1. explicit_positive_indication_predicate
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            clinical review status
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            399
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            true
            exact text
            1 INDICATIONS AND USAGE BORUZU is a proteasome inhibitor indicated for: treatment of adult patients with multiple myeloma ( 1.1 ) treatment of adult patients with mantle cell lymphoma ( 1.2 ) 1.1 Multiple Myeloma BORUZU is indicated for the treatment of adult patients with multiple myeloma. 1.2 Mantle Cell Lymphoma BORUZU is indicated for the treatment of adult patients with mantle cell lymphoma.
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            current approval status
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            extraction review status
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            generic names
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            id
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            label id
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            qualifier mentions
            1. context exact
              1 Multiple Myeloma BORUZU is indicated for the treatment of adult patients with multiple myeloma.
              kind
              age
              polarity
              not_inferred
              span
              end
              268
              end exclusive
              true
              exact text
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            regulatory links
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                end exclusive
                true
                exact text
                1.1 Multiple Myeloma BORUZU is indicated for the treatment of adult patients with multiple myeloma.
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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 indication
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                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 3 · positive indication candidate
                application numbers
                1. NDA212782
                brand names
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                classification reasons
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                clinical review status
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                context span
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                exact text
                atients with multiple myeloma ( 1.1 ) treatment of adult patients with mantle cell lymphoma ( 1.2 ) 1.1 Multiple Myeloma BORUZU is indicated for the treatment of adult patients with multiple myeloma. 1.2 Mantle Cell Lymphoma BORUZU is indicated for the treatment of adult patients with mantle cell lymphoma.
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                qualifier mentions
                1. context exact
                  ntle Cell Lymphoma BORUZU is indicated for the treatment of adult patients with mantle cell lymphoma.
                  kind
                  age
                  polarity
                  not_inferred
                  span
                  end
                  372
                  end exclusive
                  true
                  exact text
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                    exact text
                    1.2 Mantle Cell Lymphoma BORUZU is indicated for the treatment of adult patients with mantle cell lymphoma.
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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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                    structured indication
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                    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
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                    Preserved source evidence · Not medical advice