The US FDA held a Psychopharmacologic Drugs Advisory Committee (PDAC) meeting on December 1, 2015 to review Fabre-Kramer Pharmaceuticals’ Gepirone Extended Release (gepirone) for major depressive disorder (MDD). A majority of the Committee, 9 of 13 members, voted that the available data do not support a favorable benefit:risk profile for the proposed use to treat MDD.