Briefing Summary: US FDA Posts Advisory Committee Materials for Fabre-Kramer Pharmaceuticals’ Gepirone ER for Major Depressive Disorder – DEC 1, 2015 (PDAC)

The US FDA has posted details, including company and FDA Briefing Materials, for the Tuesday, December 1, 2015 Psychopharmacologic Drugs Advisory Committee (PDAC) meeting. The Committee will discuss new drug application (NDA) 21164 for gepirone hydrochloride extended-release (ER) tablets (gepirone), submitted by Fabre-Kramer Pharmaceuticals, Inc. (Fabre-Kramer), for the proposed indication of major depressive disorder (MDD).

See the SAC Tracker report