King Pharmaceuticals to resubmit Remoxy application to FDA
BRISTOL, Tenn. Drug maker King Pharmaceuticals hopes to get approval for a long-acting pain drug next year when it resubmits an approval application that the Food and Drug Administration rejected in December 2008.
The FDA rejected the application for the drug Remoxy (oxycodone) submitted last year by Pain Therapeutics, but King met with the agency earlier this month and emerged with a path to resubmit it, which it hopes to do in the middle of 2010.
King plans to submit six-month stability data with the application, though it doesn’t have to conduct new clinical trials, the company said. King assumed full responsibility for the development of the drug following the FDA’s rejection of Pain Therapeutics’ application.