PERIPHERAL & CENTRAL NERVOUS SYSTEM DRUGS ADVISORY COMMITTEE

June 6, 2001

Briefing Information

Consideratin of NDA 21-196, Xyrem (sodium oxybate, Orphan Medial Inc.), proposed to reduce the incidence of cataplexy and to improve the symptom of daytime sleepiness for persons wit narcolepsy.

Orphan Medical Presentations

Disclaimer

The statements contained in this document are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Briefing Information   pdf

Xyrem Prescription and Distribution Process, Video Script 2/2/01)  html   pdf

Video

FDA Briefing Information

Index   pdf

Overview Memo   pdf

Efficacy Review   pdf

Safety Review   pdf

Major Amendment Review   pdf

Controlled Substance Overview   pdf