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LABELS · 8683b06e-4901-4526-89ad-23a8fe2d1331

LOCAMETZ

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
2026-01-15
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 LOCAMETZ, after radiolabeling with gallium-68, is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy. with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. for selection of patients who are indicated for PSMA-directed therapy as described in the prescribing information of the therapeutic products. LOCAMETZ, after radiolabeling with gallium-68, is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level for selection of patients who are indicated for PSMA-directed therapy as described in the prescribing information of the therapeutic products. ( 1 )
Full extracted label fields
application numbers
  1. NDA215841
boxed warning exact
    brand names
    1. LOCAMETZ
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8683b06e-4901-4526-89ad-23a8fe2d1331
    generic names
    1. KIT FOR THE PREPARATION OF GALLIUM GA 68 GOZETOTIDE
    id
    8683b06e-4901-4526-89ad-23a8fe2d1331
    indications and usage exact
    1. 1 INDICATIONS AND USAGE LOCAMETZ, after radiolabeling with gallium-68, is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy. with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. for selection of patients who are indicated for PSMA-directed therapy as described in the prescribing information of the therapeutic products. LOCAMETZ, after radiolabeling with gallium-68, is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level for selection of patients who are indicated for PSMA-directed therapy as described in the prescribing information of the therapeutic products. ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Novartis Pharmaceuticals Corporation
      matched search terms
      1. cancer
      package ndcs
      1. 0078-1224-61
      product ndcs
      1. 0078-1224
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Indications and Usage ( 1 ) 3/2025 Dosage and Administration, Image Interpretation ( 2.8 ) 3/2025 Warnings and Precautions, Risk for Misinterpretation ( 5.1 ) 3/2025
      record type
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      routes
      1. INTRAVENOUS
      rxcuis
        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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        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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        substance names
        1. GOZETOTIDE
        uniis
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        1. application number
          NDA215841
          payload
          all indexed label documents
          1. Appl No
            215841
            Application Docs Date
            2026-03-02 00:00:00
            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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            Submission Type
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          2. Appl No
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            Application Docs Date
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            Application Docs ID
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            Submission No
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            Submission Type
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          all submission records
          1. Appl No
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            Review Priority
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            Submission Class Code ID
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            Submission No
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            Submission Status
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            Submission Status Date
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            Submission Type
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            Submissions Public Notes
          2. Appl No
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            Review Priority
            STANDARD
            Submission Class Code ID
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            Submission Status
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            Submission Status Date
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            Submission Type
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            Submissions Public Notes
          application number
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          approval interpretation
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          current indication status
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          latest approved submission date
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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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            Submission Type
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          official application record
          Appl No
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          Appl Public Notes
          Appl Type
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          Sponsor Name
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          openfda application present
          true
          products
          1. Active Ingredient
            GALLIUM GA-68 GOZETOTIDE
            Appl No
            215841
            Drug Name
            LOCAMETZ
            Form
            POWDER;INTRAVENOUS
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            Strength
            N/A
            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. LOCAMETZ
        classification reasons
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        clinical review status
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        true
        exact text
        1 INDICATIONS AND USAGE LOCAMETZ, after radiolabeling with gallium-68, is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy. with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. for selection of patients who are indicated for PSMA-directed therapy as described in the prescribing information of the therapeutic products. LOCAMETZ, after radiolabeling with gallium-68, is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA)-positive lesions in men
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          PSMA)-positive lesions in men with prostate
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            1 INDICATIONS AND USAGE LOCAMETZ, after radiolabeling with gallium-68, is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy. with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. for selection of patients who are indicated for PSMA-directed therapy as described in the prescribing information of the therapeutic products.
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            on elevated serum prostate-specific antigen (PSA) level. for selection of patients who are indicated for PSMA-directed therapy as described in the prescribing information of the therapeutic products. LOCAMETZ, after radiolabeling with gallium-68, is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level for selection of patients who are indicated for PSMA-directed therapy as described in the prescribing information of the therapeutic products. ( 1 )
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            is a radioactive diagnostic agent indicated
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                      Preserved source evidence · Not medical advice