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Collegium Targets Remoxy ER Through Citizen Petition Process – Again

 
• By Michael Cipriano

Citizen petition resembles July 2016 petition targeting extended-release oxycodone products, but this time names the products it's worries about.

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Collegium Pharmaceutical Inc. is arguing for FDA to apply robust standards in its review of Pain Therapeutics Inc.' Remoxy ER (oxycodone controlled-release) in a citizen petition calling for the agency to only approve the drug and other extended-release (ER) oxycodone products if their abuse-deterrent properties are as strong as those of Xtampza ER (oxycodone, extended-release), in what appears to be the drugmaker's second petition targeting Remoxy.

The April 9 petition, written by Hyman, Phelps & McNamara attorney Kurt Karst on behalf of Collegium, calls for...

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