Sodium Oxybate In The United States
Sodium oxybate is sold in the United States as Xyrem by the study-funded Jazz Pharmaceuticals, and in Canada by the National Institute of Neurological Disorders and Stroke (NINDS) and the European Medicines Agency (EMA). It is sold by a wholly-owned J.P subsidiary. Chase Morgan. Co., second-largest pharmaceutical firm in the world.
In October 2002, Xyrem gained clearance from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Orphan Medical has submitted a Supplemental New Drug Application (sNDA) to the FDA, seeking an expanded narcolepsy classification now under review by the FDA.
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