PIFLUFOLASTAT F-18
PIFLUFOLASTAT F-18 is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand names including PIFLUFOLASTAT F-18, PYLARIFY. Available dosage form: injection.
Drug Details
- Generic Name
- PIFLUFOLASTAT F-18
- Brand Names
- PIFLUFOLASTAT F-18, PYLARIFY
- Application Number
- NDA220089
- Sponsor
- Aphelion LLC
- NDC Codes
- 2
- Dosage Forms
- INJECTION
- Routes
- INTRAVENOUS
- Active Ingredients
- PIFLUFOLASTAT F-18
Indications and Usage
1 INDICATIONS AND USAGE PYLARIFY TRUVU 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 PYLARIFY TRUVU is a radioactive diagnostic drug 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 )