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LABELS · 20906e8e-8a3e-4c45-a657-6d4c1945af09

EMEND

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
2026-02-20
Captured
2026-09-09T23:37:42.544548+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE EMEND ® for injection, 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). EMEND for injection 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 ) EMEND has not been studied for treatment of established nausea and vomiting. Limitations of Use EMEND has not been studied for the treatment of established nausea and vomiting.
Full extracted label fields
application numbers
  1. NDA022023
boxed warning exact
    brand names
    1. EMEND
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8d66803a-6811-4c29-9c57-e16acfa87f21
    generic names
    1. FOSAPREPITANT DIMEGLUMINE
    id
    20906e8e-8a3e-4c45-a657-6d4c1945af09
    indications and usage exact
    1. 1 INDICATIONS AND USAGE EMEND ® for injection, 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). EMEND for injection 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 ) EMEND has not been studied for treatment of established nausea and vomiting. Limitations of Use EMEND has not been studied for the treatment of established nausea and vomiting.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Merck Sharp & Dohme LLC
      matched search terms
      1. cancer
      package ndcs
      1. 0006-3061-01
      2. 0006-3061-00
      product ndcs
      1. 0006-3061
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. INTRAVENOUS
        rxcuis
        1. 1731077
        2. 1731082
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00100.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
        100
        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=100&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%2220906e8e-8a3e-4c45-a657-6d4c1945af09%22
        spl effective date
        2026-02-20
        spl effective time
        20260220
        spl set id
        8d66803a-6811-4c29-9c57-e16acfa87f21
        spl version
        20
        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
          NDA022023
          payload
          all indexed label documents
          1. Appl No
            022023
            Application Docs Date
            2008-01-30 00:00:00
            Application Docs ID
            16783
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            022023
            Application Docs Date
            2010-03-26 00:00:00
            Application Docs ID
            16784
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            3
            Submission Type
            SUPPL
          3. Appl No
            022023
            Application Docs Date
            2013-03-26 00:00:00
            Application Docs ID
            16785
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            7
            Submission Type
            SUPPL
          4. Appl No
            022023
            Application Docs Date
            2012-07-10 00:00:00
            Application Docs ID
            16786
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            9
            Submission Type
            SUPPL
          5. Appl No
            022023
            Application Docs Date
            2014-08-13 00:00:00
            Application Docs ID
            16787
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            11
            Submission Type
            SUPPL
          6. Appl No
            022023
            Application Docs Date
            2010-03-26 00:00:00
            Application Docs ID
            38095
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            2
            Submission Type
            SUPPL
          7. Appl No
            022023
            Application Docs Date
            2010-11-17 00:00:00
            Application Docs ID
            38096
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            4
            Submission Type
            SUPPL
          8. Appl No
            022023
            Application Docs Date
            2010-03-26 00:00:00
            Application Docs ID
            38097
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            5
            Submission Type
            SUPPL
          9. Appl No
            022023
            Application Docs Date
            2017-02-07 00:00:00
            Application Docs ID
            38098
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            6
            Submission Type
            SUPPL
          10. Appl No
            022023
            Application Docs Date
            2013-04-01 00:00:00
            Application Docs ID
            38099
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            10
            Submission Type
            SUPPL
          11. Appl No
            022023
            Application Docs Date
            2017-02-15 00:00:00
            Application Docs ID
            47207
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            14
            Submission Type
            SUPPL
          12. Appl No
            022023
            Application Docs Date
            2017-06-01 00:00:00
            Application Docs ID
            48618
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            15
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            022023
            Review Priority
            STANDARD
            Submission Class Code ID
            2
            Submission No
            21
            Submission Status
            AP
            Submission Status Date
            2022-05-02 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          2. Appl No
            022023
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            19
            Submission Status
            AP
            Submission Status Date
            2019-11-14 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            022023
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            18
            Submission Status
            AP
            Submission Status Date
            2018-03-26 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            022023
            Review Priority
            PRIORITY
            Submission Class Code ID
            2
            Submission No
            17
            Submission Status
            AP
            Submission Status Date
            2018-04-03 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            022023
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            16
            Submission Status
            AP
            Submission Status Date
            2017-08-09 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            022023
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            15
            Submission Status
            AP
            Submission Status Date
            2017-05-31 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            022023
            Review Priority
            N/A
            Submission Class Code ID
            4
            Submission No
            14
            Submission Status
            AP
            Submission Status Date
            2016-12-02 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            022023
            Review Priority
            STANDARD
            Submission Class Code ID
            4
            Submission No
            12
            Submission Status
            AP
            Submission Status Date
            2015-01-12 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          9. Appl No
            022023
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            11
            Submission Status
            AP
            Submission Status Date
            2014-08-12 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          10. Appl No
            022023
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            10
            Submission Status
            AP
            Submission Status Date
            2013-03-27 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          11. Appl No
            022023
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            9
            Submission Status
            AP
            Submission Status Date
            2012-07-06 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          12. Appl No
            022023
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            7
            Submission Status
            AP
            Submission Status Date
            2013-03-20 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA022023
          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
          2022-05-02
          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
            022023
            Application Docs Date
            2022-05-04 00:00:00
            Application Docs ID
            70978
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            21
            Submission Type
            SUPPL
          official application record
          Appl No
          022023
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          MERCK AND CO INC
          openfda application present
          true
          products
          1. Active Ingredient
            FOSAPREPITANT DIMEGLUMINE
            Appl No
            022023
            Drug Name
            EMEND
            Form
            POWDER;INTRAVENOUS
            Product No
            001
            Reference Drug
            1
            Reference Standard
            0
            Strength
            EQ 115MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
            marketing status
            1. Discontinued
          2. Active Ingredient
            FOSAPREPITANT DIMEGLUMINE
            Appl No
            022023
            Drug Name
            EMEND
            Form
            POWDER;INTRAVENOUS
            Product No
            002
            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
        1. NDA022023
        brand names
        1. EMEND
        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
        668
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE EMEND ® for injection, 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). EMEND for injection 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 t
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        generic names
        1. FOSAPREPITANT DIMEGLUMINE
        id
        ind-span-4148fc7565d9c3fce22a
        label id
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        exact text
        is indicated
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        qualifier mentions
        1. context exact
          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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          polarity
          not_inferred
          span
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          end exclusive
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        3. context exact
          1 INDICATIONS AND USAGE EMEND ® for injection, 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
          kind
          regimen
          polarity
          not_inferred
          span
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          226
          end exclusive
          true
          exact text
          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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          source defined aliases
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            exact text
            1 INDICATIONS AND USAGE EMEND ® for injection, 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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            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
            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
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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). EMEND for injection 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 ) EMEND has not been studied for treatment of established nausea and vomiting. Limitations of Use EMEND has not been studied for the treatment of established nausea and vomitin
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            is a substance P/neurokinin-1 (NK 1 ) receptor antagonist, indicated
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            3. context exact
              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. 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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                      ng associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). Limitations of Use ( 1 ) EMEND has not been studied for treatment of established nausea and vomiting. Limitations of Use EMEND has not been studied for the treatment of established nausea and vomiting.
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                            Preserved source evidence · Not medical advice