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REMS Lawsuit Possible After US FDA Approves Generic Xyrem

 
• By Michael Cipriano

FDA waives requirement that Roxane's generic use same REMS as the brand; Jazz ‘intends to evaluate all potential challenges.’ Launch of generic still depends on patent litigation.

The US FDA could be facing a fight from Jazz Pharmaceuticals PLC after the agency approved a generic version of the company's narcolepsy drug Xyrem (sodium oxybate) with a Risk Evaluation and Mitigation Strategy (REMS) that uses multiple certified pharmacies and multiple databases for distribution.

FDA announced Jan. 17 that it approved the generic manufactured by Roxane Laboratories Inc., and Jazz didn't take long...

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