CANCELLED: Bone, Reproductive and Urologic Drugs Advisory Committee Advisory Committee

The US FDA has scheduled a Bone, Reproductive and Urologic Drugs Advisory Committee Advisory Committee (BRUDAC) Meeting for Tuesday, November 3, 2015 to discuss new drug application (NDA) 207959, 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).

This meeting was cancelled. The FDA stated that they no longer needed the outside, expert advice. Repros says the cancellation was due to questions regarding the bioanalytical method validation that could affect interpretability of certain pivotal study data.