Veru announces Tadalafil, Finasteride combination meets FDA requirements
Veru announced that the clinical trial of the company's proprietary Tadalafil and Finasteride combination tablet met the FDA requirements for bioavailability and bioequivalence for the co-administration of tadalafil 5mg and finasteride 5mg dosed daily for benign prostatic hyperplasia, or BPH. Stability testing of commercially manufactured batches of the Tad-Fin Combination Tablet required for submission of a new drug application, or NDA, is in progress. The company has also requested a pre-NDA meeting with FDA and anticipates submitting an NDA under the 505 regulatory pathway in the second half of calendar year 2019. Tad-Fin Combination Tablet combines tadalafil and finasteride, that are currently prescribed separately to treat lower urinary tract symptoms caused by an enlarged prostate also known as BPH. The co-administration of tadalafil and finasteride has been shown clinically to be more efficacious in treating BPH symptoms than either tadalafil or finasteride alone.