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 pdfXyrem Prescription and Distribution Process, Video Script 2/2/01) html pdf
FDA Briefing Information
Index pdf
Overview Memo pdf
Efficacy Review pdf
Safety Review pdf
Major Amendment Review pdf
Controlled Substance Overview pdf