Xyrem Risk Management Plan Should Limit Drug's Use To Cataplexy - Cmte.
Executive Summary
Orphan Medical's Xyrem risk management program should limit physician use of the gamma hydroxy butyrate product to treatment of cataplexy, FDA's Peripheral & Central Nervous System Drugs Advisory Committee said at its June 6 meeting.
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Xyrem Risk Management Requires Patient Evaluation Every Three Months
Orphan Medical's risk management program for its cataplexy drug Xyrem will require a patient evaluation by the prescribing physician every three months