FDA Bans Generic OxyContin

• The U.S. Food and Drug Administration have announced that it would not approve generic versions of the powerful narcotic OxyContin.

• The decision marks the first time the agency has allowed a manufacturer to state that a narcotic drug has tamper-resistant properties, said an agency official, Dr. Douglas C. Throckmorton.

• "The data show that, when compared to original OxyContin, reformulated OxyContin has an increased ability to resist crushing, breaking, and dissolution using a variety of tools and solvents," FDA said in the notice posted in the Federal Register. 

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• Throckmorton added that the FDA had looked at data from several studies, some of it underwritten by Purdue Pharma, in arriving at its decision, and that while the data was not perfect, the agency had concluded that it was enough to show that the new version of OxyContin was safer, in its abuse resistance, than the original version.