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LABELS · e597a26e-e04a-4f91-8c7c-a83243286396

Nexavar

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
2023-08-28
Captured
2026-09-09T23:38:02.384588+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE NEXAVAR is a kinase inhibitor indicated for the treatment of • Unresectable hepatocellular carcinoma ( 1.1 ) • Advanced renal cell carcinoma ( 1.2 ) • Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment ( 1.3 ) 1.1 Hepatocellular Carcinoma NEXAVAR ® is indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC). 1.2 Renal Cell Carcinoma NEXAVAR is indicated for the treatment of patients with advanced renal cell carcinoma (RCC). 1.3 Differentiated Thyroid Carcinoma NEXAVAR is indicated for the treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) that is refractory to radioactive iodine treatment.
Full extracted label fields
application numbers
  1. NDA021923
boxed warning exact
    brand names
    1. Nexavar
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b50667e4-5ebc-4968-a646-d605058dbef0
    generic names
    1. SORAFENIB
    id
    e597a26e-e04a-4f91-8c7c-a83243286396
    indications and usage exact
    1. 1 INDICATIONS AND USAGE NEXAVAR is a kinase inhibitor indicated for the treatment of • Unresectable hepatocellular carcinoma ( 1.1 ) • Advanced renal cell carcinoma ( 1.2 ) • Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment ( 1.3 ) 1.1 Hepatocellular Carcinoma NEXAVAR ® is indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC). 1.2 Renal Cell Carcinoma NEXAVAR is indicated for the treatment of patients with advanced renal cell carcinoma (RCC). 1.3 Differentiated Thyroid Carcinoma NEXAVAR is indicated for the treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) that is refractory to radioactive iodine treatment.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Bayer HealthCare Pharmaceuticals Inc.
      matched search terms
      1. carcinoma
      package ndcs
      1. 50419-488-58
      2. 50419-489-01
      product ndcs
      1. 50419-488
      2. 50419-489
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. ORAL
        rxcuis
        1. 597747
        2. 615979
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00700.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
        700
        total
        830
        sha256
        24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
        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=700&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%22e597a26e-e04a-4f91-8c7c-a83243286396%22
        spl effective date
        2023-08-28
        spl effective time
        20230828
        spl set id
        b50667e4-5ebc-4968-a646-d605058dbef0
        spl version
        40
        substance names
        1. SORAFENIB
        uniis
        1. 9ZOQ3TZI87
        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
          NDA021923
          payload
          all indexed label documents
          1. Appl No
            021923
            Application Docs Date
            2007-11-19 00:00:00
            Application Docs ID
            16569
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            6
            Submission Type
            SUPPL
          2. Appl No
            021923
            Application Docs Date
            2010-10-28 00:00:00
            Application Docs ID
            16570
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            9
            Submission Type
            SUPPL
          3. Appl No
            021923
            Application Docs Date
            2011-03-28 00:00:00
            Application Docs ID
            16571
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            11
            Submission Type
            SUPPL
          4. Appl No
            021923
            Application Docs Date
            2011-10-20 00:00:00
            Application Docs ID
            16572
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            12
            Submission Type
            SUPPL
          5. Appl No
            021923
            Application Docs Date
            2013-06-18 00:00:00
            Application Docs ID
            16573
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            14
            Submission Type
            SUPPL
          6. Appl No
            021923
            Application Docs Date
            2013-10-31 00:00:00
            Application Docs ID
            16574
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            15
            Submission Type
            SUPPL
          7. Appl No
            021923
            Application Docs Date
            2006-01-06 00:00:00
            Application Docs ID
            37877
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          8. Appl No
            021923
            Application Docs Date
            2007-11-19 00:00:00
            Application Docs ID
            37878
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            4
            Submission Type
            SUPPL
          9. Appl No
            021923
            Application Docs Date
            2007-11-19 00:00:00
            Application Docs ID
            37879
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            5
            Submission Type
            SUPPL
          10. Appl No
            021923
            Application Docs Date
            2007-11-19 00:00:00
            Application Docs ID
            37880
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            7
            Submission Type
            SUPPL
          11. Appl No
            021923
            Application Docs Date
            2010-10-28 00:00:00
            Application Docs ID
            37881
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            8
            Submission Type
            SUPPL
          12. Appl No
            021923
            Application Docs Date
            2013-11-22 00:00:00
            Application Docs ID
            37882
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            16
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            021923
            Review Priority
            N/A
            Submission Class Code ID
            4
            Submission No
            26
            Submission Status
            AP
            Submission Status Date
            2023-08-28 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          2. Appl No
            021923
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            25
            Submission Status
            AP
            Submission Status Date
            2021-05-20 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            021923
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            24
            Submission Status
            AP
            Submission Status Date
            2020-07-09 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            021923
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            23
            Submission Status
            AP
            Submission Status Date
            2020-04-02 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            021923
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            22
            Submission Status
            AP
            Submission Status Date
            2020-06-19 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            021923
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            20
            Submission Status
            AP
            Submission Status Date
            2018-12-06 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            021923
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            19
            Submission Status
            AP
            Submission Status Date
            2018-12-06 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            021923
            Review Priority
            STANDARD
            Submission Class Code ID
            2
            Submission No
            18
            Submission Status
            AP
            Submission Status Date
            2017-12-22 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          9. Appl No
            021923
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            17
            Submission Status
            AP
            Submission Status Date
            2014-12-02 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          10. Appl No
            021923
            Review Priority
            PRIORITY
            Submission Class Code ID
            2
            Submission No
            16
            Submission Status
            AP
            Submission Status Date
            2013-11-22 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          11. Appl No
            021923
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            15
            Submission Status
            AP
            Submission Status Date
            2013-10-30 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          12. Appl No
            021923
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            14
            Submission Status
            AP
            Submission Status Date
            2013-06-11 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA021923
          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
          2023-08-28
          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
            021923
            Application Docs Date
            2023-09-25 00:00:00
            Application Docs ID
            75547
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            26
            Submission Type
            SUPPL
          official application record
          Appl No
          021923
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          BAYER HLTHCARE
          openfda application present
          true
          products
          1. Active Ingredient
            SORAFENIB TOSYLATE
            Appl No
            021923
            Drug Name
            NEXAVAR
            Form
            TABLET;ORAL
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            Strength
            EQ 200MG 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. NDA021923
        brand names
        1. Nexavar
        classification reasons
        1. explicit_positive_indication_predicate
        2. no_tumor_directed_keyword_in_positive_statement
        clinical review status
        pending
        content role
        positive_indication_candidate
        context span
        end
        284
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE NEXAVAR is a kinase inhibitor indicated for the treatment of • Unresectable hepatocellular carcinoma ( 1.1 ) • Advanced renal cell carcinoma ( 1.2 ) • Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactiv
        label id
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        source text sha256
        8c2317f4577435eb47a6e4212623933004b8eb68f58aa7f0055f2378c193a261
        start
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        current approval status
        not_reconciled
        duplicate text group
        dup-4a044d329319ba08183d
        extraction review status
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        generic names
        1. SORAFENIB
        id
        ind-span-221e3a6b04b428805944
        label id
        e597a26e-e04a-4f91-8c7c-a83243286396
        positive predicate support span
        end
        63
        end exclusive
        true
        exact text
        is a kinase inhibitor indicated
        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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        start
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        qualifier mentions
          regulatory links
            schema version
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            source batch sha256
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            source defined aliases
              source span
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              84
              end exclusive
              true
              exact text
              1 INDICATIONS AND USAGE NEXAVAR is a kinase inhibitor indicated for the treatment of
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              source text sha256
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              start
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              source url
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              spl effective date
              2023-08-28
              spl set id
              b50667e4-5ebc-4968-a646-d605058dbef0
              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
              non_oncology_or_unclear_candidate
              Passage 2 · unclassified context
              application numbers
              1. NDA021923
              brand names
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              clinical review status
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              content role
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              332
              end exclusive
              true
              exact text
              1 INDICATIONS AND USAGE NEXAVAR is a kinase inhibitor indicated for the treatment of • Unresectable hepatocellular carcinoma ( 1.1 ) • Advanced renal cell carcinoma ( 1.2 ) • Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment ( 1.3 ) 1.1 Hepatocellular Ca
              label id
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              duplicate text group
              dup-ce01e12b2f66893afab1
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              generic names
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              id
              ind-span-3f1ae51be4940bdca7f5
              label id
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              positive predicate support span
              Source null
              qualifier mentions
              1. context exact
                • Unresectable hepatocellular carcinoma ( 1.1 )
                kind
                stage_or_setting
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                end exclusive
                true
                exact text
                Unresectable hepatocellular carcinoma ( 1
                label id
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                offset unit
                unicode_code_points
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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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                source defined aliases
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                  end exclusive
                  true
                  exact text
                  • Unresectable hepatocellular carcinoma ( 1.1 )
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                  offset unit
                  unicode_code_points
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                  source url
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                  spl effective date
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                  spl set id
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                  Passage 3 · unclassified context
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                  1 INDICATIONS AND USAGE NEXAVAR is a kinase inhibitor indicated for the treatment of • Unresectable hepatocellular carcinoma ( 1.1 ) • Advanced renal cell carcinoma ( 1.2 ) • Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment ( 1.3 ) 1.1 Hepatocellular Carcinoma NEXAVAR ® is indicated for the t
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                  regulatory links
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                      end exclusive
                      true
                      exact text
                      • Advanced renal cell carcinoma ( 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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                      structured fields status
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                      Source null
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                      biomarker and test
                      Source null
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                      Source null
                      limitations
                      Source null
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                      Source null
                      prior therapy
                      Source null
                      regimen
                      Source null
                      tumor histology
                      Source null
                      use intent
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                      Passage 4 · unclassified context
                      application numbers
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                      brand names
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                      classification reasons
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                                      Preserved source evidence · Not medical advice