The US FDA has scheduled a joint meeting of the Anesthetic and Analgesic Drug Products Advisory (AADPAC) and the Drug Safety and Risk Management Advisory Committee (DSRM) meeting for Monday to Tuesday, March 13-14, 2017.
The Committees will be asked to discuss the following:
· the abuse of generic oxymorphone extended-release (ER) and oxymorphone immediate-release (IR) products; and
· safety issues with OPANA ER (oxymorphone hydrochloride tablets) by Endo Pharmaceuticals Inc. (Endo), pre- and post-marketing data about the abuse of OPANA ER, and the overall risk-benefit of this product.
See the SAC Tracker report