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ARTICLE | Company News

FDA approves abuse-deterrent labeling for OxyContin

April 17, 2013 12:11 AM UTC

FDA said it will not accept or approve ANDAs for generic versions of OxyContin oxycodone that lack abuse-deterrent properties. The news follows the agency's approval of abuse-deterrent labeling for the reformulated version of the pain drug from Purdue Pharma L.P. (Stamford, Conn.), as well as the agency's determination that the NDA for the original formulation was withdrawn for reasons of safety or effectiveness. The new labeling indicates that the reformulated product has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via the intranasal route. The updated label does note that abuse of OxyContin via injection, intranasal and oral routes is still possible. ...