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LABELS · 5de36f8a-cbc2-4884-8fcf-e9302d41c2f8

Varubi

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
2020-08-19
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 VARUBI ® is indicated in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. VARUBI is a substance P/neurokinin 1 (NK1) receptor antagonist indicated in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. ( 1 )
Full extracted label fields
application numbers
  1. NDA206500
boxed warning exact
    brand names
    1. Varubi
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a52896cd-4a98-49b8-82db-bf1985a64d97
    generic names
    1. ROLAPITANT
    id
    5de36f8a-cbc2-4884-8fcf-e9302d41c2f8
    indications and usage exact
    1. 1 INDICATIONS AND USAGE VARUBI ® is indicated in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. VARUBI is a substance P/neurokinin 1 (NK1) receptor antagonist indicated in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. TerSera Therapeutics LLC
      matched search terms
      1. cancer
      package ndcs
      1. 70720-101-02
      product ndcs
      1. 70720-101
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Dosage and Administration ( 2 ) 8/2020 Contraindications ( 4 ) 8/2020
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
      1. 1665503
      2. 1673373
      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
      a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
      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=400&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%225de36f8a-cbc2-4884-8fcf-e9302d41c2f8%22
      spl effective date
      2020-08-19
      spl effective time
      20200819
      spl set id
      a52896cd-4a98-49b8-82db-bf1985a64d97
      spl version
      3
      substance names
      1. ROLAPITANT HYDROCHLORIDE
      uniis
      1. 57O5S1QSAQ
      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
        NDA206500
        payload
        all indexed label documents
        1. Appl No
          206500
          Application Docs Date
          2015-09-02 00:00:00
          Application Docs ID
          19723
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          206500
          Application Docs Date
          2018-04-16 00:00:00
          Application Docs ID
          53686
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          3
          Submission Type
          SUPPL
        3. Appl No
          206500
          Application Docs Date
          2020-08-20 00:00:00
          Application Docs ID
          64324
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          8
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          206500
          Review Priority
          STANDARD
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2015-09-01 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          206500
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2016-04-04 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          206500
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          2
          Submission Status
          AP
          Submission Status Date
          2016-04-22 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          206500
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          3
          Submission Status
          AP
          Submission Status Date
          2018-04-13 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          206500
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          8
          Submission Status
          AP
          Submission Status Date
          2020-08-19 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA206500
        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
        2020-08-19
        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
          206500
          Application Docs Date
          2020-08-20 00:00:00
          Application Docs ID
          64324
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          8
          Submission Type
          SUPPL
        official application record
        Appl No
        206500
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        TERSERA
        openfda application present
        true
        products
        1. Active Ingredient
          ROLAPITANT HYDROCHLORIDE
          Appl No
          206500
          Drug Name
          VARUBI
          Form
          TABLET;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
          Strength
          EQ 90MG 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. NDA206500
      brand names
      1. Varubi
      classification reasons
      1. explicit_positive_indication_predicate
      2. supportive_or_complication_use_words
      clinical review status
      pending
      content role
      positive_indication_candidate
      context span
      end
      490
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE VARUBI ® is indicated in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. VARUBI is a substance P/neurokinin 1 (NK1) receptor antagonist indicated in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initia
      label id
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      unicode_code_points
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      source text sha256
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      current approval status
      not_reconciled
      duplicate text group
      dup-655eb76201cc5cc5aa5c
      extraction review status
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      generic names
      1. ROLAPITANT
      id
      ind-span-5c34ebac410b5f968da1
      label id
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      positive predicate support span
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      end exclusive
      true
      exact text
      is indicated
      label id
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      source text sha256
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      qualifier mentions
      1. context exact
        is indicated in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associate
        kind
        age
        polarity
        not_inferred
        span
        end
        99
        end exclusive
        true
        exact text
        adults
        label id
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        offset unit
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      2. context exact
        1 INDICATIONS AND USAGE VARUBI ® is indicated in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemothe
        kind
        regimen
        polarity
        not_inferred
        span
        end
        225
        end exclusive
        true
        exact text
        in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherap
        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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          true
          exact text
          1 INDICATIONS AND USAGE VARUBI ® is indicated in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.
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          unicode_code_points
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          source text sha256
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          start
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          source url
          https://api.fda.gov/drug/label.json?search=id%3A%225de36f8a-cbc2-4884-8fcf-e9302d41c2f8%22
          spl effective date
          2020-08-19
          spl set id
          a52896cd-4a98-49b8-82db-bf1985a64d97
          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
          supportive_care_candidate
          Passage 2 · positive indication candidate
          application numbers
          1. NDA206500
          brand names
          1. Varubi
          classification reasons
          1. explicit_positive_indication_predicate
          2. supportive_or_complication_use_words
          clinical review status
          pending
          content role
          positive_indication_candidate
          context span
          end
          614
          end exclusive
          true
          exact text
          n adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. VARUBI is a substance P/neurokinin 1 (NK1) receptor antagonist indicated in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. ( 1 )
          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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          current approval status
          not_reconciled
          duplicate text group
          dup-426e2ab57c185779a411
          extraction review status
          automated_candidate_pending_source_review
          generic names
          1. ROLAPITANT
          id
          ind-span-90363b89241bb3d51f7b
          label id
          5de36f8a-cbc2-4884-8fcf-e9302d41c2f8
          positive predicate support span
          end
          363
          end exclusive
          true
          exact text
          is a substance P/neurokinin 1 (NK1) receptor antagonist indicated
          label id
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          offset unit
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          qualifier mentions
          1. context exact
            st indicated in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associate
            kind
            age
            polarity
            not_inferred
            span
            end
            417
            end exclusive
            true
            exact text
            adults
            label id
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            start
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          2. context exact
            ubstance P/neurokinin 1 (NK1) receptor antagonist indicated in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemothe
            kind
            regimen
            polarity
            not_inferred
            span
            end
            543
            end exclusive
            true
            exact text
            in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherap
            label id
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          regulatory links
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            source defined aliases
              source span
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              608
              end exclusive
              true
              exact text
              VARUBI is a substance P/neurokinin 1 (NK1) receptor antagonist indicated in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic 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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              biomarker and test
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              disease stage
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              limitations
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              line
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              prior therapy
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              regimen
              Source null
              tumor histology
              Source null
              use intent
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              Passage 3 · unclassified context
              application numbers
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              clinical review status
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              end exclusive
              true
              exact text
              n adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. ( 1 )
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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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                    approval pathway
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                    biomarker and test
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                    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