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PIFLUFOLASTAT F-18

FDA Drug Profile — PYLARIFY

Drug Details

Generic Name
PIFLUFOLASTAT F-18
Brand Names
PYLARIFY
Application Number
NDA214793
Sponsor
Progenics Pharmaceuticals, Inc.
NDC Codes
1
Dosage Forms
INJECTION
Routes
INTRAVENOUS
Active Ingredients
PIFLUFOLASTAT F-18

Indications and Usage

1 INDICATIONS AND USAGE PYLARIFY 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 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 )