Anesthetic and Analgesic Drug Products and the Drug Safety and Risk Management Advisory Committees

On Thursday, May 5, 2016, the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and the Drug Safety and Risk Management (DSRM) Advisory Committee jointly supported, by a vote of 16-Yes to 4-No, with no abstentions, the safety and efficacy of Apadaz (benzhydrocodone/acetaminophen oral tablets, also referred to as KP201/APAP), submitted by KemPharm, Inc. (KemPharm). The proposed indication is short-term (up to 14 days) management of acute pain. The PDUFA goal date is June 9, 2016