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

On Tuesday, June 7, 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 14-Yes to 3-No, with no abstentions, the safety and efficacy of VANTRELA ER (hydrocodone bitartrate extended-release (ER) tablets). A new drug application (NDA) was submitted by Teva Branded Pharmaceutical Products R&D, Inc., (Teva) for the full proposed indication of the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The Committees also voted in regard to proposed abuse-deterrent labeling claims.