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Sleep / Sleep disorders / Food and Drug Administration / Pharmaceutical industry / Xyrem / New Drug Application / Gamma-Hydroxybutyric acid / Prescription medication / Narcolepsy / Medicine / Health / Pharmacology


Document Date: 2009-04-01 17:21:03

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City

Minnetonka / /

Company

M.D. / Orphan Medical Inc. / /

Event

FDA Phase / /

Facility

Robert Temple / /

IndustryTerm

telephone conversation / drug product / /

MedicalCondition

narcolepsy / cataplexy / /

MedicalTreatment

Clinical protocols / /

Movie

Page 3 2 / /

Organization

Division of Neuropharmacological Drug Products / Food and Drug Administration / Center for Drug Evaluation and Research Enclosures / DEPARTMENT OF HEALTH / Division of Drug Marketing / Advertising and Communications / /

Person

Dayton Reardan / /

Position

Professional Labeling Patient Medication Guide Risk Management Plan Post Marketing Evaluation Program Physician / Director Office / Vice President / Regulatory Affairs / /

Product

Professional Labeling Patient Medication / Xyrem / Xyrem® (sodium oxybate) Oral / Xyrem® Oral Solution / /

ProvinceOrState

Indiana / Minnesota / /

PublishedMedium

the Medication Guide / /

Technology

pharmacokinetics / approval Clinical protocols / /

SocialTag