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FDA Actions on OxyContin Products, 4/16/2013

FDA has determined that the reformulated version of OxyContin has abuse-deterrent properties and has approved new labeling that indicates that the product has physical and chemical properties that are expected to make abuse by injection difficult and to reduce abuse via the intranasal route.

FDA also has determined that the original formulation of OxyContin was withdrawn from the market for safety reasons. As a result, the agency will not accept or approve any abbreviated new drug applications (generics) that rely upon the approval of these products. 
 

Page Last Updated: 10/29/2014
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