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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.