Purdue Petition Seeks FDA Commitment To “Adapted” Studies For OxyContin Generics

04 Dec 2013

• By Cathy Dombrowski

Company says a generic should be equivalent or better than reformulated OxyContin on all the tests to ensure it has equivalent abuse-deterrent capabilities.

A Purdue Pharma LP citizen petition aims to put FDA on the record as to which studies manufacturers must conduct to demonstrate that a generic has abuse-deterrence equivalent to that of reformulated OxyContin (oxycodone hydrochloride extended-release).

The studies are similar to those conducted by Purdue for reformulated OxyContin, but are “adapted for the purpose of showing...