Used in scans for prostate cancer. NDA 214793, held by Progenics Pharms Inc. Piflufolastat F-18.
As of Nov 14, 2026, NDA 214793 (Pylarify), held by Progenics Pharms Inc, was first approved by FDA on May 26, 2021, with 0 approved supplements and 0 published complete response letters.
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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 26, 2021 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pylarify50ML (1-80mCi/ML) · solution;intravenous | Piflufolastat F-18 | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
