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`PERIPH ERAL
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`http ://www ..fda gov/ohrns/dockets/ac/O1lbriefing/3754b1. htm
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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 NBA 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 ofthe product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor‘s
`statements. FDA has not made a final detennination about the safety or effectiveness ofthe product described in this document.
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`Briefing Information fl
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`Xyrem Prescription and Distribution Process, Video Script 2/2/01) m pdf
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`m
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`FDA Briefing Information
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`Index pif
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`Overview Memo p_d_f
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`Efficacy Review pfl
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`Safety Review pdf
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`Major Amendment Review fl
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`Controlled Substance Overview @
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`https://web.archive.org lweb/20010701233052/http://\AMNV.fda.g oWohrms/doclets/ac/m /briefi ng/3754b1 .htm
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`1/1
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`PAR1019
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`CBM of US. Patent No. 7,668,730
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