Veru Announces Successful Completion of Pre-NDA Meeting with FDA for TADFIN (Tadalafil 5mg and Finasteride 5mg) Combination for the Treatment of Benign Prostatic Hyperplasia

--Reached Agreement with FDA on Regulatory Package for NDA Submission Utilizing the 505(b)(2) Expedited Regulatory Pathway— -- TADFIN is a First Novel Combination Formulation of Tadalafil and Finasteride for the Treatment of BPH with NDA Submission Anticipated in Summer of 2020--  MIAMI , June 26,

June 26th, 2019|