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.
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Earlier Event: November 24Peripheral and Central Nervous System Drugs Advisory Committee
Later Event: December 3Secretary's Advisory Committee on Human Research Protections (SACHRP)