Orphan Medical Xyrem
Peripheral & Central Nervous System Drugs Advisory Committee will review sodium oxybate for the reduction of the incidence of cataplexy and the improvement of daytime sleepiness in people with narcolepsy June 6. The committee will review safety and efficacy as well as risk-management issues associated with the drug. Internal systems for control, including manufacturing and distribution systems, will likely be discussed. The committee will meet at the Holiday Inn in Bethesda, Md. at 8 a.m. Xyrem was originally set for review March 15 but the agency requested a clarification of data from trials not sponsored by Orphan Medical. The firm anticipates FDA action July 2, following a 90-day extension of the priority review deadline
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