Kit for the preparation of gallium Ga 68 gozetotide injection
Drug Details
- Generic Name
- Kit for the preparation of gallium Ga 68 gozetotide injection
- Brand Names
- ILLUCCIX
- Application Number
- NDA214032
- Sponsor
- Telix Pharmaceuticals (US) Inc.
- NDC Codes
- 1
- Dosage Forms
- KIT
- Routes
- INTRAVENOUS
- Active Ingredients
- N/A
Indications and Usage
1 INDICATIONS AND USAGE ILLUCCIX, 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 For selection of patients who are indicated for PSMA-directed therapy as described in the prescribing information of the therapeutic products ILLUCCIX, 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 For selection of patients who are indicated for PSMA-directed therapy as described in the prescribing information of the therapeutic products ( 1 )