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LABELS · bc79f63b-8a05-41b5-a349-f71f1313e791

NAVITRUX

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
2026-07-29
Captured
2026-09-09T23:37:58.719708+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE NAVITRUX, in combination with other antiemetic agents, is indicated in adults and pediatric patients 6 months of age and older 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 NAVITRUX has not been studied for the treatment of established nausea and vomiting. NAVITRUX is a substance P/neurokinin-1 (NK 1 ) receptor antagonist, indicated in adults and pediatric patients 6 months of age and older, 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 ) NAVITRUX has not been studied for treatment of established nausea and vomiting.
Full extracted label fields
application numbers
  1. NDA220436
boxed warning exact
    brand names
    1. NAVITRUX
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a41b7c3a-1376-43a7-b5b9-6ba2eba1e169
    generic names
    1. FOSAPREPITANT
    id
    bc79f63b-8a05-41b5-a349-f71f1313e791
    indications and usage exact
    1. 1 INDICATIONS AND USAGE NAVITRUX, in combination with other antiemetic agents, is indicated in adults and pediatric patients 6 months of age and older 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 NAVITRUX has not been studied for the treatment of established nausea and vomiting. NAVITRUX is a substance P/neurokinin-1 (NK 1 ) receptor antagonist, indicated in adults and pediatric patients 6 months of age and older, 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 ) NAVITRUX has not been studied for treatment of established nausea and vomiting.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. AVYXA Pharma, LLC
      matched search terms
      1. cancer
      package ndcs
      1. 83831-153-01
      product ndcs
      1. 83831-153
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. INTRAVENOUS
        rxcuis
        1. 1731077
        2. 2745874
        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
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        source url
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        spl effective date
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        spl effective time
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        substance names
        1. FOSAPREPITANT DIMEGLUMINE
        uniis
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        Drugs@FDA application source records
        1. application number
          NDA220436
          payload
          all indexed label documents
          1. Appl No
            220436
            Application Docs Date
            2026-06-29 00:00:00
            Application Docs ID
            86384
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
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            Submission Type
            ORIG
          all submission records
          1. Appl No
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            Review Priority
            STANDARD
            Submission Class Code ID
            15
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2026-06-24 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          application number
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          approval interpretation
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          has approved submission record
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          latest label selection rule
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          latest posted label documents
          1. Appl No
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            Application Docs Date
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            Application Docs ID
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            Application Docs Title
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            Application Docs Type ID
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            Submission No
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          official application record
          Appl No
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          Appl Public Notes
          Appl Type
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          Sponsor Name
          AVYXA HOLDINGS
          openfda application present
          true
          products
          1. Active Ingredient
            FOSAPREPITANT DIMEGLUMINE
            Appl No
            220436
            Drug Name
            NAVITRUX
            Form
            POWDER;INTRAVENOUS
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            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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        1 INDICATIONS AND USAGE NAVITRUX, in combination with other antiemetic agents, is indicated in adults and pediatric patients 6 months of age and older 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 NAVITRUX has not been studied for the treatment of established nausea and vomiting. NAVITRUX is a substance P/neurokinin-1 (NK 1 ) receptor antagonist, indicated in adults and pedi
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          1 INDICATIONS AND USAGE NAVITRUX, in combination with other antiemetic agents, is indicated in adults and pediatric patients 6 months of age and older for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogen
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            1 INDICATIONS AND USAGE NAVITRUX, in combination with other antiemetic agents, is indicated in adults and pediatric patients 6 months of age and older 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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            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 NAVITRUX has not been studied for the treatment of established nausea and vomiting. NAVITRUX is a substance P/neurokinin-1 (NK 1 ) receptor antagonist, indicated in adults and pediatric patients 6 months of age and older, in combination with other antiemetic agents, for the preventi
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                  g associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). Limitations of Use NAVITRUX has not been studied for the treatment of established nausea and vomiting. NAVITRUX is a substance P/neurokinin-1 (NK 1 ) receptor antagonist, indicated in adults and pediatric patients 6 months of age and older, 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 ) NAVITRUX has not been studied for treatment of established nausea and vomiting.
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                      NAVITRUX is a substance P/neurokinin-1 (NK 1 ) receptor antagonist, indicated in adults and pediatric patients 6 months of age and older, 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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                          schema version
                          0.1.0
                          source batch sha256
                          a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
                          source defined aliases
                            source span
                            end
                            1157
                            end exclusive
                            true
                            exact text
                            Limitations of Use ( 1 ) NAVITRUX has not been studied for treatment of established nausea and vomiting.
                            label id
                            bc79f63b-8a05-41b5-a349-f71f1313e791
                            offset unit
                            unicode_code_points
                            source array index
                            0
                            source field
                            indications_and_usage_exact
                            source text sha256
                            7c63ea11077e7687b7f8528b346b52a93908c34e9bc643d1c7cb9d8954c4eafb
                            start
                            1053
                            source url
                            https://api.fda.gov/drug/label.json?search=id%3A%22bc79f63b-8a05-41b5-a349-f71f1313e791%22
                            spl effective date
                            2026-07-29
                            spl set id
                            a41b7c3a-1376-43a7-b5b9-6ba2eba1e169
                            spl version
                            7
                            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
                            not_applicable

                            Preserved source evidence · Not medical advice