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FDA Approves Updated Label for Reformulated OxyContin

FDA Approves Updated Label for Reformulated OxyContin

Reformulated OxyContin has physical, chemical properties that should cut potential for abuse

FRIDAY, April 19 (HealthDay News) -- The U.S. Food and Drug Administration has approved updated labeling for Purdue Pharma L.P.'s reformulated OxyContin (oxycodone hydrochloride controlled-release) tablets, which will indicate that the reformulated product has physical and chemical properties that should make abuse by injection very difficult and reduce intranasal abuse.

Abuse of original OxyContin, noted since approval of the original formulation in 1995, often followed manipulation, causing a more rapid release of the drug and increased the risk of adverse events. The FDA approved reformulated OxyContin in April 2010, which was designed to be more difficult to manipulate and abuse. The new tablet is difficult to crush, break, or dissolve, and cannot be prepared easily for injections.

As the therapeutic benefits of original OxyContin are the same as those of reformulated OxyContin, but with the potential for specific types of abuse, the FDA determined that original OxyContin be withdrawn from sale for reasons of safety or effectiveness. The FDA will not accept or approve applications for new drugs (generics) that rely on the approval of original OxyContin.

"The development of abuse-deterrent opioid analgesics is a public health priority for the FDA," Douglas Throckmorton, M.D., deputy director for regulatory programs in the FDA's Center for Drug Evaluation and Research, said in a statement. "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 by injection difficult and expected to reduce abuse by snorting compared to original OxyContin."

More Information (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm348252.htm )