Background Analysis: US FDA Advisory Committee to Review Repros Therapeutics’ Enclomiphene for Hypogonadism – NOV 3, 2015 (BRUDAC)
The US FDA has scheduled a Bone, Reproductive and Urologic Advisory Committee (BRUDAC) Meeting for Thursday, November 3, 2015 to discuss new drug application (NDA) 207959 for enclomiphene citrate 12.5 milligram (mg) and 25 mg capsules, submitted by Repros Therapeutics, Inc., (Repros) for the proposed treatment of secondary hypogonadism in fertile men (men with more than 15 million sperm/milliliter (ml), younger than 60 years of age with a Body Mass Index (BMI) over 25 kilograms (kg)/meters squared (m2).