FDA to Block Generic Versions of OxyContin to Deter Abuse

Apr 17, 2013

The Food and Drug Administration announced Tuesday that it would block generic, crushable versions of OxyContin from coming to the market and approve the reformulated, non-crushable OxyContin, which deters abuse of the powerful painkiller.

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U.S. Senate Republican Leader Mitch McConnell applauded the move. “Given the public health epidemic of prescription drug abuse and the ravaging effects it has on families all across Kentucky, this announcement is great news and will prevent an influx of crushable, generic OxyContin from coming to market,” McConnell said in a release.
OxyContin is a potent drug designed to treat severe pain. Without abuse-deterrent formulas, addicts can crush the pills to get an immediate heroin-like high. The reformulated product has properties that make the tablet harder to crush, break, or dissolve and that prevent it from being injected in order to achieve a quick high, an FDA press release said.

Drug overdoses are now the leading cause of death in Kentucky, and law enforcement, lawmakers and health providers have expressed their concerns that crushable, generic versions would worsen the problem.

The FDA decision came on the same day manufacturer Purdue Pharma’s patent on the original drug was set to expire, and McConnell has been actively meeting with federal officials on behalf of those concerned.

“I applaud FDA Commissioner Hamburg for her decision and I look forward to continuing working with her on the issue on behalf of my constituents in Kentucky,” said McConnell. (Read more)