Posted by Michael Wonder on 25 Feb 2021
Veru submits new drug application for proprietary Tadfin for benign prostatic hyperplasia
23 February 2021 - FDA PDUFA date is expected in December 2021.
Veru today announced that it has submitted a 505(b)(2) new drug application with the U.S. FDA for Tadfin (tadalafil 5 mg and finasteride 5 mg) capsules, a novel oral daily dosing combination formulation, for the treatment of benign prostatic hyperplasia.
