FDA Actions on OxyContin Products, 4/16/2013
FDA has determined that the reformulated version of OxyContin has abuse-deterrent properties and has approved new labeling that indicates that the product has physical and chemical properties that are expected to make abuse by injection difficult and to reduce abuse via the intranasal route.
FDA also has determined that the original formulation of OxyContin was withdrawn from the market for safety reasons. As a result, the agency will not accept or approve any abbreviated new drug applications (generics) that rely upon the approval of these products.
FDA approves abuse-deterrent labeling for reformulated OxyContin
FDA news releases (4/16/2013)
Determination that the OxyContin (oxycodone hydrochloride) Drug Products Covered by New Drug Application 20–553 Were Withdrawn from Sale for Reasons of Safety or Effectiveness
Federal Register notice
Office Director Memo: Abuse-Deterrent Properties of Purdue’s Reformulated OxyContin Extended-Release Tablets
- Supplemental Approval Letter
Oxycontin Label The Science of Abuse-Deterrence – Progress Toward Creating Safer Opioids
FDA Voice Blog
- Additional Information on OxyContin