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LABELS · 0ef109ec-d2f8-4c22-b20d-65db7f9c85a0

FOCINVEZ

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
2026-04-17
Captured
2026-09-09T23:37:39.774134+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE FOCINVEZ, 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 FOCINVEZ has not been studied for the treatment of established nausea and vomiting. FOCINVEZ 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) FOCINVEZ has not been studied for treatment of established nausea and vomiting.
Full extracted label fields
application numbers
  1. NDA216686
boxed warning exact
    brand names
    1. FOCINVEZ
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7afe33d8-5416-465a-b98b-f4eedc327a94
    generic names
    1. FOSAPREPITANT DIMEGLUMINE
    id
    0ef109ec-d2f8-4c22-b20d-65db7f9c85a0
    indications and usage exact
    1. 1 INDICATIONS AND USAGE FOCINVEZ, 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 FOCINVEZ has not been studied for the treatment of established nausea and vomiting. FOCINVEZ 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) FOCINVEZ has not been studied for treatment of established nausea and vomiting.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Amneal Pharmaceuticals LLC
      matched search terms
      1. cancer
      package ndcs
      1. 70121-2631-1
      product ndcs
      1. 70121-2631
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. RECENT MAJOR CHANGES Dosage and Administration ( 2.3 ) 03/2026
      record type
      complete_spl_indications_section_candidate
      routes
      1. INTRAVENOUS
      rxcuis
      1. 2664065
      2. 2664071
      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
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      830
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      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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      substance names
      1. FOSAPREPITANT DIMEGLUMINE
      uniis
      1. D35FM8T64X
      verification flags
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      2. spl_text_not_verified_identical_to_latest_approved_label
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      Drugs@FDA application source records
      1. application number
        NDA216686
        payload
        all indexed label documents
        1. Appl No
          216686
          Application Docs Date
          2023-08-23 00:00:00
          Application Docs ID
          75272
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          216686
          Application Docs Date
          2025-05-30 00:00:00
          Application Docs ID
          82365
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          2
          Submission Type
          SUPPL
        3. Appl No
          216686
          Application Docs Date
          2026-03-31 00:00:00
          Application Docs ID
          85604
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          4
          Submission Type
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        all submission records
        1. Appl No
          216686
          Review Priority
          STANDARD
          Submission Class Code ID
          12
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2023-08-22 00:00:00
          Submission Type
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          Submissions Public Notes
        2. Appl No
          216686
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          2
          Submission Status
          AP
          Submission Status Date
          2025-05-29 00:00:00
          Submission Type
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          Submissions Public Notes
        3. Appl No
          216686
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          4
          Submission Status
          AP
          Submission Status Date
          2026-03-30 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA216686
        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
        2026-03-30
        latest label selection rule
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        latest posted label documents
        1. Appl No
          216686
          Application Docs Date
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          Application Docs ID
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          Application Docs Title
          0
          Application Docs Type ID
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          Submission No
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          Submission Type
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        official application record
        Appl No
        216686
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        STERISCIENCE
        openfda application present
        true
        products
        1. Active Ingredient
          FOSAPREPITANT DIMEGLUMINE
          Appl No
          216686
          Drug Name
          FOCINVEZ
          Form
          SOLUTION;INTRAVENOUS
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
          Strength
          EQ 150MG BASE/50ML (EQ 3MG BASE/ML)
          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. NDA216686
      brand names
      1. FOCINVEZ
      classification reasons
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      2. supportive_or_complication_use_words
      clinical review status
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      content role
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      context span
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      true
      exact text
      1 INDICATIONS AND USAGE FOCINVEZ, 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 FOCINVEZ has not been studied for the treatment of established nausea and vomiting. FOCINVEZ is a substance P/neurokinin-1 (NK 1 ) receptor antagonist, indicated in adults and pedi
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        n combination with other antiemetic agents, is indicated in adults and pediatric patients 6 months of age and older for the pr
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      3. context exact
        1 INDICATIONS AND USAGE FOCINVEZ, 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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        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 a
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          exact text
          1 INDICATIONS AND USAGE FOCINVEZ, 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 FOCINVEZ has not been studied for the treatment of established nausea and vomiting. FOCINVEZ 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 FOCINVEZ has not been studied for the treatment of established nausea and vomiting. FOCINVEZ 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) FOCINVEZ has not been studied for treatment of established nausea and vomiting.
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                    FOCINVEZ 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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                    Source null
                    prior therapy
                    Source null
                    regimen
                    Source null
                    tumor histology
                    Source null
                    use intent
                    supportive_care_candidate
                    Passage 4 · limitation of use
                    application numbers
                    1. NDA216686
                    brand names
                    1. FOCINVEZ
                    classification reasons
                    1. negative_or_not_established_clause
                    clinical review status
                    pending
                    content role
                    limitation_of_use
                    context span
                    end
                    1154
                    end exclusive
                    true
                    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 (1) FOCINVEZ has not been studied for treatment of established nausea and vomiting.
                    label id
                    0ef109ec-d2f8-4c22-b20d-65db7f9c85a0
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    cdfeb600d345c0c197de75af4b3ab9cd2c9f9a7b747b14e5c0c3fca45e412826
                    start
                    852
                    current approval status
                    not_reconciled
                    duplicate text group
                    dup-7bbf7ce7a5c7bef9d66c
                    extraction review status
                    automated_candidate_pending_source_review
                    generic names
                    1. FOSAPREPITANT DIMEGLUMINE
                    id
                    ind-span-bb9d34e02c4cf1bd9e40
                    label id
                    0ef109ec-d2f8-4c22-b20d-65db7f9c85a0
                    positive predicate support span
                    Source null
                    qualifier mentions
                      regulatory links
                        schema version
                        0.1.0
                        source batch sha256
                        0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07
                        source defined aliases
                          source span
                          end
                          1154
                          end exclusive
                          true
                          exact text
                          Limitations of Use (1) FOCINVEZ has not been studied for treatment of established nausea and vomiting.
                          label id
                          0ef109ec-d2f8-4c22-b20d-65db7f9c85a0
                          offset unit
                          unicode_code_points
                          source array index
                          0
                          source field
                          indications_and_usage_exact
                          source text sha256
                          cdfeb600d345c0c197de75af4b3ab9cd2c9f9a7b747b14e5c0c3fca45e412826
                          start
                          1052
                          source url
                          https://api.fda.gov/drug/label.json?search=id%3A%220ef109ec-d2f8-4c22-b20d-65db7f9c85a0%22
                          spl effective date
                          2026-04-17
                          spl set id
                          7afe33d8-5416-465a-b98b-f4eedc327a94
                          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