FDA cancels advisory committee meeting to review Androxal (enclomiphene) for treatment of hyopgonadism- Repros Therapeutics

Repros Therapeutics announced that the Division of Bone, Reproductive and Urologic Products of the FDA has cancelled the scheduled 3 November 2015 advisory committee to review the Company's New Drug Application (NDA) for its enclomiphene product candidate, formerly known as Androxal, due to questions that arose late in the review regarding the bioanalytical method validation that could affect interpretability of certain pivotal study data.

The FDA has expressed its willingness to work with Repros to address these questions. The FDA accepted the NDA for review in April 2015 and later assigned a Prescription Drug User Fee Act (PDUFA) goal date of 30 November 2015.