ARTICLE | Clinical News
OxyContin oxycodone regulatory update
September 28, 2009 7:00 AM UTC
A joint FDA panel voted 14-4, with 1 abstention, to recommend approval of an NDA from Purdue for a reformulated version of controlled-release OxyContin oxycodone to manage moderate to severe pain. The members of FDA's Anesthetic and Life Support Drugs and Drug Safety and Risk Management advisory committees felt the new formulation was not necessarily safer than a controlled-release formulation that Purdue already markets, but agreed that in vitro data suggest it has less potential for abuse or misuse. ...