Purdue Withdraws sNDA on Reformulated OxyContin

Purdue Pharma has withdrawn its supplemental new drug application for reformulated OxyContin, causing cancelation of an FDA advisory committee meeting to discuss whether postmarket studies of the product’s extended-release tablets show reduced misuse.

Richard Fanelli, the company’s head of regulatory affairs, saysthat, “given the complexity of epidemiological research and the unprecedented nature of this exercise,” Purdue wants to complete additional analyses to “build the most compelling body of epidemiological evidence.”

The joint meeting of the FDA’s Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee had been scheduled for Tuesday and today. The meeting has not been rescheduled. — Jonathon Shacat