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Orphan Medical Xyrem NDA Filing Planned For Fourth Quarter 2000

Executive Summary

Orphan Medical will submit an NDA for the gamma hydroxybutyrate product Xyrem for the treatment of narcolepsy-associated cataplexy by early fourth quarter 2000.

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Orphan Medical Xyrem

Sodium oxybate for treatment of narcolepsy and reduction of cataplexy will be reviewed by FDA's Peripheral & Central Nervous System Drugs Advisory Committee on March 15. Risk management will be the main focus of the committee's deliberations, FDA said. The NDA, filed Oct. 10, 2000, has received priority review status (1"The Pink Sheet" Nov. 29, 1999, p. 11)

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011



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