JUN 4 BRUDAC-DSRM

Background Analysis: US FDA Advisory Committee to Review Sprout Pharmaceuticals’ Flibanserin to Treat Hypoactive Sexual Desire Disorder in Premenopausal Women – JUN 4, 2015 (BRUDAC-DSRM)

The US FDA has scheduled a Joint Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) and the Drug Safety and Risk Management Advisory Committee (DSRM) for Thursday, June 4, 2015 to discuss new drug application (NDA) 022526, flibanserin 100 milligram tablets, submitted by Sprout Pharmaceuticals Inc. (Sprout), proposed for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women.

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