June 6, 2001


Consideration of ( NDA) 21-196, Xyrem® (sodium oxybate, Orphan Medical, Inc.), proposed to reduce the incidence of cataplexy and to improve the symptom of daytime sleepiness for persons with narcolepsy. A main focus of the deliberations will be on risk management issues.

Orphan Medical Presentations   ppt   html


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.

NDA 21196 Xyrem for Narcolepsy, Orphan Medica, Inc., Comments About Sleepwalking, Ranjit Mani, MD    pdf   htm

Effect of GHB on Measures of Daytime Sleepiness in Narcolepsy, Ranjit Mani, MD   pdf   htm

GHB  the CEWG Perspective, Carol Falkowski   pdf

GHB Abuse in the United States, Carol Falkowski   ppt   htm

Gamma Hydroxybutyrate, Jo Ellen Dyer, PharmD   ppt   htm

Public Hearing

Written Testimony of Sharon A. Fitzgerald   pdf

Testimony by Abbey S. Meyers, National Organization for Rare Disorders, Inc.   pdf

Statement of Robert L Cloud, Narcolepsy Network   pdf

Statement of Cindy Pekarick   pdf

Statement of Eric C. Strain, MD, College on Problems of Drug Dependence   pdf

Public Statement of Deborah Zvosec, PhD, Hennepin County Medical Center   pdf

Zvosec, Deborah L. PhD, Stephen W. Smith, MD. et al, "Adverse Evens, Including Death, Associate with the Use of 1,4-butanediol," N Engl J Med, Vol. 344, No. 2, January 11, 2001, pp 87-94.*

Statement of Trinka Porrata   pdf

Testimony of Richard L Gelula, MSA, National Sleep Foundation   pdf   htm

"Living with Narcolepsy,"  National Sleep Foundation*

Statement of Matt Speakman    pdf

Statement of Charles F Cichon, National Association of Drug Diversion Investigators Inc   pdf

Michael's Message Foundation Inc., Debbie Alumbaugh   pdf

Statement of Brian A Hunter, Young Adults with Narcolepsy - YAWN   pdf

Statement Regarding GHB (Xyrem) Approval, Joe Spillane, PharmD, ABAT   pdf     htm   



* Copyrighted material may be view at:   Dockets Management Branch, Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD  20857, Public hours are 9:00 am – 4:00 pm Monday through Friday except for Federal Holidays.