kit for the preparation of gallium Ga 68 gozetotide
kit for the preparation of gallium Ga 68 gozetotide is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand name including LOCAMETZ. Available dosage form: injection, powder, lyophilized, for solution.
Drug Details
- Generic Name
- kit for the preparation of gallium Ga 68 gozetotide
- Brand Names
- LOCAMETZ
- Application Number
- NDA215841
- Sponsor
- Advanced Accelerator Applications USA, Inc
- NDC Codes
- 2
- Dosage Forms
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Routes
- INTRAVENOUS
- Active Ingredients
- GOZETOTIDE
Indications and Usage
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 )