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LABELS · 334df051-2b2d-01fe-e063-6394a90a05f5

Gozellix

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
2025-04-11
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 GOZELLIX, after radiolabeling with Ga 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. GOZELLIX, after radiolabeling with Ga 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. ( 1 )
Full extracted label fields
application numbers
  1. NDA219592
boxed warning exact
    brand names
    1. Gozellix
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=abeab169-e38e-433a-b8a9-f1dab31518c8
    generic names
    1. GOZETOTIDE
    id
    334df051-2b2d-01fe-e063-6394a90a05f5
    indications and usage exact
    1. 1 INDICATIONS AND USAGE GOZELLIX, after radiolabeling with Ga 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. GOZELLIX, after radiolabeling with Ga 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. ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Telix Innovations SA
      matched search terms
      1. cancer
      package ndcs
      1. 84552-500-25
      2. 84552-500-64
      3. 84552-501-25
      4. 84552-502-25
      5. 84552-503-64
      6. 84552-504-25
      product ndcs
      1. 84552-500
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
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            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
            100
            skip
            100
            total
            830
            sha256
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            url
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            source url
            https://api.fda.gov/drug/label.json?search=id%3A%22334df051-2b2d-01fe-e063-6394a90a05f5%22
            spl effective date
            2025-04-11
            spl effective time
            20250411
            spl set id
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            spl version
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            substance names
              uniis
                verification flags
                1. oncology_keyword_candidate_not_clinically_classified
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                Drugs@FDA application source records
                1. application number
                  NDA219592
                  payload
                  all indexed label documents
                  1. Appl No
                    219592
                    Application Docs Date
                    2025-03-24 00:00:00
                    Application Docs ID
                    81686
                    Application Docs Title
                    0
                    Application Docs Type ID
                    2
                    Submission No
                    1
                    Submission Type
                    ORIG
                  all submission records
                  1. Appl No
                    219592
                    Review Priority
                    STANDARD
                    Submission Class Code ID
                    15
                    Submission No
                    1
                    Submission Status
                    AP
                    Submission Status Date
                    2025-03-20 00:00:00
                    Submission Type
                    ORIG
                    Submissions Public Notes
                  application number
                  NDA219592
                  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
                  2025-03-20
                  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
                    219592
                    Application Docs Date
                    2025-03-24 00:00:00
                    Application Docs ID
                    81686
                    Application Docs Title
                    0
                    Application Docs Type ID
                    2
                    Submission No
                    1
                    Submission Type
                    ORIG
                  official application record
                  Appl No
                  219592
                  Appl Public Notes
                  Appl Type
                  NDA
                  Sponsor Name
                  TELIX INNOVATIONS
                  openfda application present
                  true
                  products
                  1. Active Ingredient
                    GALLIUM GA-68 GOZETOTIDE
                    Appl No
                    219592
                    Drug Name
                    GOZELLIX
                    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
                1. NDA219592
                brand names
                1. Gozellix
                classification reasons
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                clinical review status
                pending
                content role
                positive_indication_candidate
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                true
                exact text
                1 INDICATIONS AND USAGE GOZELLIX, after radiolabeling with Ga 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. GOZELLIX, after radiolabeling with Ga 68, is a radioactive diagnostic agent indicated for positron emission to
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                1. GOZETOTIDE
                id
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                qualifier mentions
                1. context exact
                  ion tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: With suspected metastasis who are candidates for ini
                  kind
                  biomarker
                  polarity
                  not_inferred
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                  exact text
                  PSMA) positive lesions in men with prostate
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                    exact text
                    1 INDICATIONS AND USAGE GOZELLIX, after radiolabeling with Ga 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.
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                    spl effective date
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                    structured indication
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                    Source null
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                    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
                    diagnostic_candidate
                    Passage 2 · positive indication candidate
                    application numbers
                    1. NDA219592
                    brand names
                    1. Gozellix
                    classification reasons
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                    exact text
                    itron 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. GOZELLIX, after radiolabeling with Ga 68, is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with
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                    1. GOZETOTIDE
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                    is indicated
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                          With suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
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                          spl effective date
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                          spl set id
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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
                          non_oncology_or_unclear_candidate
                          Passage 3 · positive indication candidate
                          application numbers
                          1. NDA219592
                          brand names
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                          classification reasons
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                          clinical review status
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                          end exclusive
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                          exact text
                          ions 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. GOZELLIX, after radiolabeling with Ga 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. ( 1 )
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                            ion tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: With suspected metastasis who are candidates for ini
                            kind
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                            PSMA) positive lesions in men with prostate
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                              GOZELLIX, after radiolabeling with Ga 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.
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                              itron 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. ( 1 )
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                              is a radioactive diagnostic agent indicated
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                                    With suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
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                                    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
                                    non_oncology_or_unclear_candidate
                                    Passage 5 · unclassified context
                                    application numbers
                                    1. NDA219592
                                    brand names
                                    1. Gozellix
                                    classification reasons
                                    1. no_unambiguous_positive_indication_predicate
                                    clinical review status
                                    pending
                                    content role
                                    unclassified_context
                                    context span
                                    end
                                    762
                                    end exclusive
                                    true
                                    exact text
                                    ions 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. ( 1 )
                                    label id
                                    334df051-2b2d-01fe-e063-6394a90a05f5
                                    offset unit
                                    unicode_code_points
                                    source array index
                                    0
                                    source field
                                    indications_and_usage_exact
                                    source text sha256
                                    2e862137d4fbeec6a497583ab71dff253255aef287b4116d663c95e7586bc815
                                    start
                                    557
                                    current approval status
                                    not_reconciled
                                    duplicate text group
                                    dup-8c5e687af6991c1a7dd7
                                    extraction review status
                                    automated_candidate_pending_source_review
                                    generic names
                                    1. GOZETOTIDE
                                    id
                                    ind-span-82fd3ba66c4d90c66f1a
                                    label id
                                    334df051-2b2d-01fe-e063-6394a90a05f5
                                    positive predicate support span
                                    Source null
                                    qualifier mentions
                                      regulatory links
                                        schema version
                                        0.1.0
                                        source batch sha256
                                        fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                        source defined aliases
                                          source span
                                          end
                                          762
                                          end exclusive
                                          true
                                          exact text
                                          ( 1 )
                                          label id
                                          334df051-2b2d-01fe-e063-6394a90a05f5
                                          offset unit
                                          unicode_code_points
                                          source array index
                                          0
                                          source field
                                          indications_and_usage_exact
                                          source text sha256
                                          2e862137d4fbeec6a497583ab71dff253255aef287b4116d663c95e7586bc815
                                          start
                                          757
                                          source url
                                          https://api.fda.gov/drug/label.json?search=id%3A%22334df051-2b2d-01fe-e063-6394a90a05f5%22
                                          spl effective date
                                          2025-04-11
                                          spl set id
                                          abeab169-e38e-433a-b8a9-f1dab31518c8
                                          spl version
                                          2
                                          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
                                          unclear

                                          Preserved source evidence · Not medical advice