Background Analysis: US FDA Advisory Committee to Review Titan’s Pharmaceuticals’ PROBUPHINE Implant for Opioid Maintenance– JAN 14, 2016 (PDAC)
The US FDA has scheduled a Psychopharmacologic Drugs Advisory Committee (PDAC) meeting for January 12, 2016. The Committee will discuss new drug application (NDA) 204442 for PROBUPHINE (buprenorphine hydrochloride and ethylene vinyl acetate) subdermal implant, submitted by Braeburn Pharmaceuticals, Inc. (Braeburn), on behalf of Titan Pharmaceuticals (Titan) for the proposed indication of maintenance treatment of opioid dependence.
See the SAC Tracker report