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.
See the SAC Tracker report