DEC 1 PDAC

Results Wire: US FDA Advisory Committee Does Not Support Fabre-Kramer Pharmaceuticals’ Gepirone ER for Major Depressive Disorder – DEC 1, 2015 (PDAC)

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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