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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.

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