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`PERIPHERAL
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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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`Conside ratin of NDA 21-196, Xyrem (sodium oxybate, Orphan Media] 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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`Dzsc/azmer
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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 determination about the safety or eIIectiveness ofthe product described in this document.
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`Briefing Information flf
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`Xylem Prescription and Distribution Process, Video Script 2/2/01) m flf
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`m
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`FDA Briefing Information
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`Index Mf
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`Overview Memo mf
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`Efficacy Review fl
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`Safety Review flf
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`Major Amendment Review pdf
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`Controlled Substance Overview fl
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`https://web.archive.org/Web/20010701233052/http://vwwv.fda.g ov/ohrms/dockets/ac/O1/briefing/3754b1 .htm
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`PAR1019
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`IPR of US. Patent No. 7,668,730
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`IPR of U.S. Patent No. 7,668,730
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