FDA Rejects Repros Hypogonadism Drug; Shares Tumble
This article was originally published in Scrip
Executive Summary
The FDA slapped Repros Therapeutics Inc. with a complete response letter (CRL), rejecting the company's new drug application (NDA) for enclomiphene, formerly known as Androxal, as a treatment for secondary hypogonadism in overweight men seeking to restore normal testicular function.