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LABELS · 026e2548-8de0-4776-9802-dd3fff2c2635

VOTRIENT

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
2025-12-16
Captured
2026-09-09T23:37:39.774134+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: HEPATOTOXICITY Severe and fatal hepatotoxicity has been observed in clinical trials. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended [see Warnings and Precautions (5.1)]. WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning. Severe and fatal hepatotoxicity has been observed in clinical trials. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended. ( 5.1 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE VOTRIENT is a kinase inhibitor indicated for the treatment of adults with: advanced renal cell carcinoma (RCC). ( 1.1 ) advanced soft tissue sarcoma (STS) who have received prior chemotherapy. ( 1.2 ) Limitations of Use : The efficacy of VOTRIENT for the treatment of patients with adipocytic soft tissue sarcoma or gastrointestinal stromal tumors has not been demonstrated. 1.1 Renal Cell Carcinoma VOTRIENT ® is indicated for the treatment of adults with advanced renal cell carcinoma (RCC). 1.2 Soft Tissue Sarcoma VOTRIENT is indicated for the treatment of adults with advanced soft tissue sarcoma (STS) who have received prior chemotherapy. Limitations of Use : The efficacy of VOTRIENT for the treatment of patients with adipocytic STS or gastrointestinal stromal tumors has not been demonstrated.
Full extracted label fields
application numbers
  1. NDA022465
boxed warning exact
  1. WARNING: HEPATOTOXICITY Severe and fatal hepatotoxicity has been observed in clinical trials. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended [see Warnings and Precautions (5.1)]. WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning. Severe and fatal hepatotoxicity has been observed in clinical trials. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended. ( 5.1 )
brand names
  1. VOTRIENT
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=eeaaaf38-fb86-4d9f-a19d-0f61daac2fd7
generic names
  1. PAZOPANIB HYDROCHLORIDE
id
026e2548-8de0-4776-9802-dd3fff2c2635
indications and usage exact
  1. 1 INDICATIONS AND USAGE VOTRIENT is a kinase inhibitor indicated for the treatment of adults with: advanced renal cell carcinoma (RCC). ( 1.1 ) advanced soft tissue sarcoma (STS) who have received prior chemotherapy. ( 1.2 ) Limitations of Use : The efficacy of VOTRIENT for the treatment of patients with adipocytic soft tissue sarcoma or gastrointestinal stromal tumors has not been demonstrated. 1.1 Renal Cell Carcinoma VOTRIENT ® is indicated for the treatment of adults with advanced renal cell carcinoma (RCC). 1.2 Soft Tissue Sarcoma VOTRIENT is indicated for the treatment of adults with advanced soft tissue sarcoma (STS) who have received prior chemotherapy. Limitations of Use : The efficacy of VOTRIENT for the treatment of patients with adipocytic STS or gastrointestinal stromal tumors has not been demonstrated.
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Novartis Pharmaceuticals Corporation
    matched search terms
    1. carcinoma
    2. sarcoma
    3. tumors
    package ndcs
    1. 0078-1077-66
    product ndcs
    1. 0078-1077
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
      1. 867502
      2. 867506
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00000.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
      0
      total
      830
      sha256
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      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=0&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%22026e2548-8de0-4776-9802-dd3fff2c2635%22
      spl effective date
      2025-12-16
      spl effective time
      20251216
      spl set id
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      spl version
      15
      substance names
      1. PAZOPANIB HYDROCHLORIDE
      uniis
      1. 33Y9ANM545
      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
        NDA022465
        payload
        all indexed label documents
        1. Appl No
          022465
          Application Docs Date
          2009-10-20 00:00:00
          Application Docs ID
          17605
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          022465
          Application Docs Date
          2011-10-25 00:00:00
          Application Docs ID
          17606
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          3
          Submission Type
          SUPPL
        3. Appl No
          022465
          Application Docs Date
          2012-04-27 00:00:00
          Application Docs ID
          17607
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          10
          Submission Type
          SUPPL
        4. Appl No
          022465
          Application Docs Date
          2012-03-23 00:00:00
          Application Docs ID
          17608
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          11
          Submission Type
          SUPPL
        5. Appl No
          022465
          Application Docs Date
          2012-04-27 00:00:00
          Application Docs ID
          17609
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          12
          Submission Type
          SUPPL
        6. Appl No
          022465
          Application Docs Date
          2013-08-15 00:00:00
          Application Docs ID
          17610
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          14
          Submission Type
          SUPPL
        7. Appl No
          022465
          Application Docs Date
          2013-08-15 00:00:00
          Application Docs ID
          17611
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          16
          Submission Type
          SUPPL
        8. Appl No
          022465
          Application Docs Date
          2014-11-20 00:00:00
          Application Docs ID
          17612
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          19
          Submission Type
          SUPPL
        9. Appl No
          022465
          Application Docs Date
          2015-04-01 00:00:00
          Application Docs ID
          17613
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          20
          Submission Type
          SUPPL
        10. Appl No
          022465
          Application Docs Date
          2015-10-06 00:00:00
          Application Docs ID
          17614
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          21
          Submission Type
          SUPPL
        11. Appl No
          022465
          Application Docs Date
          2016-05-23 00:00:00
          Application Docs ID
          17615
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          22
          Submission Type
          SUPPL
        12. Appl No
          022465
          Application Docs Date
          2010-05-07 00:00:00
          Application Docs ID
          38734
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          2
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          022465
          Review Priority
          UNKNOWN
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2009-10-19 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          022465
          Review Priority
          UNKNOWN
          Submission Class Code ID
          3
          Submission No
          2
          Submission Status
          AP
          Submission Status Date
          2010-04-27 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          022465
          Review Priority
          UNKNOWN
          Submission Class Code ID
          3
          Submission No
          3
          Submission Status
          AP
          Submission Status Date
          2011-10-21 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          022465
          Review Priority
          UNKNOWN
          Submission Class Code ID
          3
          Submission No
          5
          Submission Status
          AP
          Submission Status Date
          2011-10-21 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          022465
          Review Priority
          N/A
          Submission Class Code ID
          21
          Submission No
          6
          Submission Status
          AP
          Submission Status Date
          2011-04-21 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          022465
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          7
          Submission Status
          AP
          Submission Status Date
          2012-01-12 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          022465
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          10
          Submission Status
          AP
          Submission Status Date
          2012-04-26 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          022465
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          11
          Submission Status
          AP
          Submission Status Date
          2012-03-20 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          022465
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          12
          Submission Status
          AP
          Submission Status Date
          2012-04-26 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        10. Appl No
          022465
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          13
          Submission Status
          AP
          Submission Status Date
          2012-11-15 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        11. Appl No
          022465
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          14
          Submission Status
          AP
          Submission Status Date
          2013-08-14 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        12. Appl No
          022465
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          15
          Submission Status
          AP
          Submission Status Date
          2013-08-14 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA022465
        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
        2024-01-25
        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
          022465
          Application Docs Date
          2024-01-26 00:00:00
          Application Docs ID
          77312
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          36
          Submission Type
          SUPPL
        official application record
        Appl No
        022465
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        NOVARTIS
        openfda application present
        true
        products
        1. Active Ingredient
          PAZOPANIB HYDROCHLORIDE
          Appl No
          022465
          Drug Name
          VOTRIENT
          Form
          TABLET;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
          Strength
          EQ 200MG BASE
          marketing status
          1. Prescription
        2. Active Ingredient
          PAZOPANIB HYDROCHLORIDE
          Appl No
          022465
          Drug Name
          VOTRIENT
          Form
          TABLET;ORAL
          Product No
          002
          Reference Drug
          1
          Reference Standard
          0
          Strength
          EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
          marketing status
          1. Discontinued

      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. NDA022465
      brand names
      1. VOTRIENT
      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
      335
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE VOTRIENT is a kinase inhibitor indicated for the treatment of adults with: advanced renal cell carcinoma (RCC). ( 1.1 ) advanced soft tissue sarcoma (STS) who have received prior chemotherapy. ( 1.2 ) Limitations of Use : The efficacy of VOTRIENT for the treatment of patients with adipocytic soft tissue sarcom
      label id
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      current approval status
      not_reconciled
      duplicate text group
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      extraction review status
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      generic names
      1. PAZOPANIB HYDROCHLORIDE
      id
      ind-span-7534fede14db0a70f3a5
      label id
      026e2548-8de0-4776-9802-dd3fff2c2635
      positive predicate support span
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      end exclusive
      true
      exact text
      is a kinase inhibitor indicated
      label id
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      qualifier mentions
      1. context exact
        TRIENT is a kinase inhibitor indicated for the treatment of adults with: advanced renal cell carcinoma (RCC).
        kind
        age
        polarity
        not_inferred
        span
        end
        92
        end exclusive
        true
        exact text
        adults
        label id
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      2. context exact
        inase inhibitor indicated for the treatment of adults with: advanced renal cell carcinoma (RCC).
        kind
        stage_or_setting
        polarity
        not_inferred
        span
        end
        134
        end exclusive
        true
        exact text
        advanced renal cell carcinoma (RCC)
        label id
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        source text sha256
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      regulatory links
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        source defined aliases
          source span
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          135
          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE VOTRIENT is a kinase inhibitor indicated for the treatment of adults with: advanced renal cell carcinoma (RCC).
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          start
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          source url
          https://api.fda.gov/drug/label.json?search=id%3A%22026e2548-8de0-4776-9802-dd3fff2c2635%22
          spl effective date
          2025-12-16
          spl set id
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          spl version
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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
          tumor_directed_candidate
          Passage 2 · unclassified context
          application numbers
          1. NDA022465
          brand names
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          clinical review status
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          416
          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE VOTRIENT is a kinase inhibitor indicated for the treatment of adults with: advanced renal cell carcinoma (RCC). ( 1.1 ) advanced soft tissue sarcoma (STS) who have received prior chemotherapy. ( 1.2 ) Limitations of Use : The efficacy of VOTRIENT for the treatment of patients with adipocytic soft tissue sarcoma or gastrointestinal stromal tumors has not been demonstrated. 1.1 Renal Cell Ca
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          id
          ind-span-3c9ece8c4a8f63ac02e3
          label id
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          positive predicate support span
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          1. context exact
            ( 1.1 ) advanced soft tissue sarcoma (STS) who have received prior chemotherapy.
            kind
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          2. context exact
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            who have received prior chemotherapy
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          regulatory links
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              exact text
              ( 1.1 ) advanced soft tissue sarcoma (STS) who have received prior chemotherapy.
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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
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              structured indication
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              Source null
              approval pathway
              Source null
              biomarker and test
              Source null
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              Source null
              limitations
              Source null
              line
              Source null
              prior therapy
              Source null
              regimen
              Source null
              tumor histology
              Source null
              use intent
              unclear
              Passage 3 · limitation of use
              application numbers
              1. NDA022465
              brand names
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              classification reasons
              1. negative_or_not_established_clause
              clinical review status
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              content role
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              context span
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              end exclusive
              true
              exact text
              USAGE VOTRIENT is a kinase inhibitor indicated for the treatment of adults with: advanced renal cell carcinoma (RCC). ( 1.1 ) advanced soft tissue sarcoma (STS) who have received prior chemotherapy. ( 1.2 ) Limitations of Use : The efficacy of VOTRIENT for the treatment of patients with adipocytic soft tissue sarcoma or gastrointestinal stromal tumors has not been demonstrated. 1.1 Renal Cell Carcinoma VOTRIENT ® is indicated for the treatment of adults with advanced renal cell carcinoma (RCC). 1.2 Soft Tissue Sarcoma VOTRIENT is indicated for the treatment of adults with a
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              offset unit
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                                  Preserved source evidence · Not medical advice