Joint Meeting of the Bone, Reproductive, and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee

The US FDA held a joint meeting of the Bone, Reproductive, and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee for Thursday, June 4, 2015. The Committees jointly supported approval of Addyi (flibanserin 100 mg tablets) by Sprout Pharmaceuticals Inc. (Sprout) for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. In particular, 18 members voted “Yes, but only if certain risk management options beyond labeling are implemented.” Six members voted “No.” There were no votes for the other option, “Yes, with labeling alone to manage the risks.”

See the FDA Announcement