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# Lantheus NDA for Pylarify New Formulation
- URL: https://www.fdaweb.com/lantheus-nda-for-pylarify-new-formulation/
- Published: 2025-08-06T12:00:00.000Z
- Updated: 2026-09-14T15:18:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159639

FDA has accepted a Lantheus NDA for a new formulation of its Pylarify F 18 prostate-specific membrane antigen (PSMA) imaging agent, submitted by its affiliate, Aphelion. The agency has set a user fee review action target date of 3/6/2026.

The new formulation builds on Lantheus’ current prostate cancer imaging agent, Pylarify (piflufolastat F 18) and its use for detecting recurrent prostate cancer in men with rising prostate-specific antigen (PSA) levels. According to Lantheus, the updated formulation is expected to maintain the same diagnostic efficacy while significantly increasing manufacturing efficiency — potentially boosting the number of doses per batch by about 50%.

Approved for PET imaging of PSMA-positive lesions in men with prostate cancer, Pylarify helps clinicians assess both suspected metastasis and disease recurrence, according to the company. It combines PSMA targeting with fluorine-18 radiolabeling for high diagnostic clarity and has been used in more than 500,000 scans across the U.S., it adds.