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`PERIPHERAL
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`http://w w w .fda.gov/ohrms/dockets/ac/01/briefing/3754b1.htm
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`41 captures
`1 Jul 01 - 21 Jan 13
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`2000
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`PERIPHERAL & CENTRAL NERVOUS SYSTEM DRUGS ADVISORY COMMITTEE
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`June 6, 2001
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`Briefing Information
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`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.
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`Orphan Medical Presentations
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`Disclaimer
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`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.
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`Briefing Information pdf
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`Xyrem Prescription and Distribution Process, Video Script 2/2/01) html pdf
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`Video
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`FDA Briefing Information
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`Index pdf
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`Overview Memo pdf
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`Efficacy Review pdf
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`Safety Review pdf
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`Major Amendment Review pdf
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`Controlled Substance Overview pdf
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`https://web.archive.org/web/20010701233052/http://www.fda.gov/ohrms/dockets/ac/01/briefing/3754b1.htm
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`ROX 1019
`CBM of U.S. Patent No. 7,765,107
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