Background Analysis: US FDA Advisory Committee to Review Fabre-Kramer Pharmaceuticals’ Gepirone for Major Depressive Disorder – DEC 1, 2015 (PDAC)

The U.S. FDA has scheduled a Psychopharmacologic Advisory Committee (PDAC) Meeting for Tuesday, December 1, 2015 to discuss new drug application (NDA) 21164 for gepirone hydrochloride extended-release tablets, submitted by Fabre-Kramer Pharmaceuticals, Inc. (Fabre-Kramer), for the proposed indication of major depressive disorder.

See the SAC Tracker report