Benzhydrocodone/acetaminophen regulatory update

FDA’s Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management advisory committees will meet on May 5 to discuss an NDA for KemPharm’s KP201/APAP for short-term management of acute pain. The NDA for the oral, abuse-deterrent formulation of benzhydrocodone -- a hydrocodone prodrug -- and acetaminophen is under Priority Review, with a June 9 PDUFA date. ...