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Panel to Discuss NDA for Hypogonadism


Federal Register Notice: FDA’s Bone, Reproductive, and Urologic Drugs Advisory Committee will meet 11/3, from 8:30 a.m. to 5 p.m. at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD. The committee will discuss a Repros Therapeutics NDA, enclomiphene citrate 12.5 mg and 25 mg capsules for the proposed treatment of secondary hypogonadism in fertile men (men with more than 15 million sperm/ ml), younger than 60 years of age with a Body Mass Index (BMI) over 25 kg/meters squared. Contact Kalyani Bhatt, (301) 796-9001, email: BRUDAC@fda.hhs.gov. To view this notice, click here.