flotufolastat F-18
Drug Details
- Generic Name
- flotufolastat F-18
- Brand Names
- POSLUMA
- Application Number
- NDA216023
- Sponsor
- Blue Earth Diagnostics
- NDC Codes
- 1
- Dosage Forms
- INJECTION
- Routes
- INTRAVENOUS
- Active Ingredients
- FLOTUFOLASTAT F-18
Indications and Usage
1 INDICATIONS AND USAGE POSLUMA 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. POSLUMA 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 )