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OxyContin Revised Labeling Expects Less Abuse Via Injection, Snorting

 
• By Cathy Dombrowski

There will be no generics of original OxyContin; FDA says it can no longer serve as a reference product because it has a greater abuse potential than the reformulation, where Purdue has secured particularly strong language regarding reducing intranasal abuse.

Revised labeling for Purdue Pharma LP’s reformulated OxyContin (oxycodone HCl controlled-release) approved by FDA on April 16 allows the company to market the drug with a claim for reduced abuse by injection and snorting and eliminates the possibility of generic competition based on the original formula.

“In vitro data demonstrate that OxyContin has physicochemical properties expected to make abuse via injection difficult,” labeling says, while data...

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