FDA Committees Recommend Approval for Reformulated OxyContin

September 25, 2009
Two FDA advisory committees voted 14–4 with one abstention to recommend approval of Purdue Pharma’s reformulated version of long-acting OxyContin designed to be abuse-deterrent, despite some members’ concerns over the drug’s safety. The reformulated version of OxyContin (oxycodone HCl) would be slightly safer than the current product, although it’s hard to say how much safer it will be for the majority of users, David Margolis, professor of dermatology and epidemiology at the University of Pennsylvania, said.
Drug Industry Daily