Used in scans for prostate cancer. NDA 220089, held by Aphelion. Piflufolastat F-18.
As of Nov 13, 2026, NDA 220089 (Pylarify Truvu), held by Aphelion, was first approved by FDA on Mar 6, 2026, with 0 approved supplements and 0 published complete response letters.
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
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 6, 2026 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pylarify Truvu1mCi/mL-120mCi/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
