Narcolepsy - Xyrem Articles
June - 2005
- Positive Opinion for UCBs Xyrem For the Treatment of Cataplexy in Adults with Narcolepsy
Source: TalkAboutSleep.com (Press release)
March - 2005
- FDA Accepts Xyrem sNDA for Review, User Fee Deadline Set for November 18, 2005
Source: TalkAboutSleep.com
January - 2005
- Orphan Medical Announces Fourth Quarter 2004 Xyrem Prescription Levels Up 9%
Source: TalkAboutSleep.com - Orphan Medical Submits Xyrem sNDA to Include Improvement in Other Primary Symptoms of Narcolepsy
Source: TalkAboutSleep.com
December - 2004
- Orphan Medical Announces Patient Enrollment is Complete in Clinical Trial Assessing Xyrem for the Treatment of Fibromyalgia Syndrome
Source: TalkAboutSleep.com
November - 2004
- Xyrem - A Promising Treatment For Narcolepsy?
Source: TalkAboutSleep.com - Orphan Medical Announces Acceptance of Xyrem Filing in Europe
Source: TalkAboutSleep.com - Orphan Medical Issues Xyrem Prescriptions Update
Source: TalkAboutSleep.com
September - 2004
- Orphan Medical Announces Positive Xyrem Clinical Results in Second Excessive Daytime Sleepiness Trial - Trial Supports Use of Xyrem as Monotherapy for Narcolepsy
Source: TalkAboutSleep.com
August - 2004
- Orphan Medical Issues Xyrem Prescriptions Update
Source: TalkAboutSleep.com
July - 2004
- Orphan Medical Announces the Completion of Clinical Portion of EXCEEDS Excessive Daytime Sleepiness Trial
Source: TalkAboutSleep.com - Orphan Medical Issues Xyrem Prescriptions Update
Source: TalkAboutSleep.com
March - 2004
- Orphan Medical Announces the Completion of Patient Enrollment for Excessive Daytime Sleepiness Trial
Source: TalkAboutSleep.com
December - 2002
- Orphan Medical Announces Positive Notification for European Orphan Product Designation for Xyrem
Source: TalkAboutSleep.com - Orphan Medical Provides Update on Prescription Levels for Xyrem
Source: TalkAboutSleep.com - Orphan Medical Update on FDA Review of Xyrem
Source: TalkAboutSleep.com
October - 2002
- Orphan Medical Announces the Commercial Launch of Xyrem Through A Dedicated Specialty Sales Force
Source: TalkAboutSleep.com
July - 2002
- Orphan Medical Announces FDA Approval of Xyrem
Source: TalkAboutSleep.com
February - 2002
- Study Shows Xyrem Effectiveness
Source: TalkAboutSleep.com
November - 2001
- Orphan Medical Announces That Xyrem Manufacturer Cleared by FDA
Source: TalkAboutSleep.com - Orphan Medical Announces Xyrem Response Accepted for Review by the FDA
Source: TalkAboutSleep.com
September - 2001
- FDA Accepts Orphan Medical Plan Regarding Xyrem NDA
Source: TalkAboutSleep.com
July - 2001
- Reaction to Xyrem's Approvable Status Posted July 4, 2001
Source: TalkAboutSleep.com - Xyrem Approvable Pending Resolution of Issues
Source: TalkAboutSleep.com
June - 2001
- FDA Advisory Committee Finds Xyrem Effective for Treating Cataplexy
Source: TalkAboutSleep.com - New Sites Added - Narcolepsy Clinical Trial - Participate In Research
Source: TalkAboutSleep.com
May - 2001
- Xyrem Demonstrates Overall Improvement for Narcolepsy Patients
Source: TalkAboutSleep.com
March - 2001
- Orphan Medical Reports on Xyrem NDA Developments
Source: TalkAboutSleep.com
January - 2001
- Orphan Medical Offers Update on Clinical Trials
Source: TalkAboutSleep.com
October - 2000
- Xyrem Receives Priority Review Status From FDA
Source: TalkAboutSleep.com
August - 2000
- Xyrem - One Drug Two Faces
Source: TalkAboutSleep.com
April - 2000
- FDA Sets Date for Xyrem Review Meeting
Source: TalkAboutSleep.com
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