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LABELS · 89783971-3346-4ff8-ac47-d824a7ddf75d

Fosaprepitant

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
2022-06-30
Captured
2026-09-09T23:37:54.830918+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Fosaprepitant for Injection, in combination with other antiemetic agents, is indicated in adults for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin. delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). Limitations of Use Fosaprepitant for Injection has not been studied for the treatment of established nausea and vomiting. Fosaprepitant for Injection is a substance P/neurokinin-1 (NK 1 ) receptor antagonist, indicated in adults, in combination with other antiemetic agents, for the prevention of ( 1 ): acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin. delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). Limitations of Use ( 1 ) Fosaprepitant for Injection has not been studied for treatment of established nausea and vomiting.
Full extracted label fields
application numbers
  1. NDA210064
boxed warning exact
    brand names
    1. Fosaprepitant
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9dbd4c29-d894-4839-9b22-a2f65c8c8ad1
    generic names
    1. FOSAPREPITANT
    id
    89783971-3346-4ff8-ac47-d824a7ddf75d
    indications and usage exact
    1. 1 INDICATIONS AND USAGE Fosaprepitant for Injection, in combination with other antiemetic agents, is indicated in adults for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin. delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). Limitations of Use Fosaprepitant for Injection has not been studied for the treatment of established nausea and vomiting. Fosaprepitant for Injection is a substance P/neurokinin-1 (NK 1 ) receptor antagonist, indicated in adults, in combination with other antiemetic agents, for the prevention of ( 1 ): acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin. delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). Limitations of Use ( 1 ) Fosaprepitant for Injection has not been studied for treatment of established nausea and vomiting.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Actavis Pharma, Inc.
      matched search terms
      1. cancer
      package ndcs
      1. 0591-4385-79
      product ndcs
      1. 0591-4385
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. INTRAVENOUS
        rxcuis
        1. 1731077
        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
        limit
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        skip
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        total
        830
        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. FOSAPREPITANT DIMEGLUMINE
        uniis
        1. D35FM8T64X
        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
          NDA210064
          payload
          all indexed label documents
          1. Appl No
            210064
            Application Docs Date
            2019-09-06 00:00:00
            Application Docs ID
            59936
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          all submission records
          1. Appl No
            210064
            Review Priority
            STANDARD
            Submission Class Code ID
            15
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2019-09-05 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          application number
          NDA210064
          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
            210064
            Application Docs Date
            2019-09-06 00:00:00
            Application Docs ID
            59936
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
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            Submission Type
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          official application record
          Appl No
          210064
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          TEVA PHARMS USA
          openfda application present
          true
          products
          1. Active Ingredient
            FOSAPREPITANT DIMEGLUMINE
            Appl No
            210064
            Drug Name
            FOSAPREPITANT DIMEGLUMINE
            Form
            POWDER;INTRAVENOUS
            Product No
            001
            Reference Drug
            0
            Reference Standard
            0
            Strength
            EQ 150MG BASE/VIAL
            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
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        brand names
        1. Fosaprepitant
        classification reasons
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        clinical review status
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        content role
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        context span
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        625
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE Fosaprepitant for Injection, in combination with other antiemetic agents, is indicated in adults for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin. delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). Limitations of Use Fosaprepitant for Injection has not been studied for the treatment of established nausea and vomiting. Fosaprepitant for Injection is a substance P/neurokinin-1 (NK 1 ) receptor an
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        generic names
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        id
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        exact text
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        qualifier mentions
        1. context exact
          n combination with other antiemetic agents, is indicated in adults for the prevention of: acute and delayed nausea and vomitin
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        2. context exact
          1 INDICATIONS AND USAGE Fosaprepitant for Injection, in combination with other antiemetic agents, is indicated in adults for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose
          kind
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          true
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          in combination with other antiemetic agents, is indicated in adults for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of high
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            exact text
            1 INDICATIONS AND USAGE Fosaprepitant for Injection, in combination with other antiemetic agents, is indicated in adults for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin. delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).
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            spl effective date
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            biomarker and test
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            use intent
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            exact text
            f highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin. delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). Limitations of Use Fosaprepitant for Injection has not been studied for the treatment of established nausea and vomiting. Fosaprepitant for Injection is a substance P/neurokinin-1 (NK 1 ) receptor antagonist, indicated in adults, in combination with other antiemetic agents, for the prevention of ( 1 ): acute and delayed
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            positive predicate support span
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                  source url
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                  Passage 3 · positive indication candidate
                  application numbers
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                  exact text
                  nitial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). Limitations of Use Fosaprepitant for Injection has not been studied for the treatment of established nausea and vomiting. Fosaprepitant for Injection is a substance P/neurokinin-1 (NK 1 ) receptor antagonist, indicated in adults, in combination with other antiemetic agents, for the prevention of ( 1 ): acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin. delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). Limitations of Use ( 1 ) Fosaprepitant for Injection has not been studied for treatment of established nausea and vomiting.
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                    rokinin-1 (NK 1 ) receptor antagonist, indicated in adults, in combination with other antiemetic agents, for the prevention of ( 1 ): acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin. delaye
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                    in combination with other antiemetic agents, for the prevention of ( 1 ): acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic can
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                      Fosaprepitant for Injection is a substance P/neurokinin-1 (NK 1 ) receptor antagonist, indicated in adults, in combination with other antiemetic agents, for the prevention of ( 1 ): acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin. delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).
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                            Source null
                            regimen
                            Source null
                            tumor histology
                            Source null
                            use intent
                            not_applicable

                            Preserved source evidence · Not medical advice