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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.

Vertical stack of multicolor office binders with Statements tags 3D rendering

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

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