FDA approves new labeling for OxyContin

Posted by Pharmacist on April 23, 2013

The U.S. Food and Drug Administration announced April 16, 2013 approval for the updated labeling of Purdue Pharma L.P.’s reformulated OxyContin (oxycodone hydrochloride controlled-release) tablets. This follows the reformulation of the drug that was launched in April 2010. The new properties of the tablets are intended to make it more difficult to abuse the drug by snorting or injecting it.

Douglas Throckmorton, M.D. is the deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. In the announcement he said “The development of abuse-deterrent opioid analgesics is a public health priority for the FDA. While both original and reformulated OxyContin are subject to abuse and misuse, the FDA has determined that reformulated OxyContin can be expected to make abuse…(more difficult) compared to original OxyContin.”

The reformulated tablet is more difficult to dissolve, crush or break than the original version; when attempts to prepare it for injection are made it forms a viscous hydrogel.

Assessment of the effects of the reformulated drug on abuse will continue and the FDA will review the data as it becomes available.

It was also announced that because the benefits of the original formula of OxyContin no longer outweigh its risks and the drug was removed from sale due to safety or effectiveness issues. This means the FDA will not review or approve any generics that depend on the approval of original OxyContin.


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