Public Comment Audio for FDA Advisory Meeting Sodium Oxybate for Fibromyalgia
Hear NFA president, Lynne Matallana, Neurologist Dr. Victor Rosenfeld, researcher Dr. Muhammad B. Yunus, and many people who have been successfully treated by sodium oxybate for fibromyalgia.
FDASodiumOxybatePublicComment1 Lynne Matallana Fibromyalgia Association President
FDASodiumOxybatePublicComment2 Victor Rosenfeld
FDASodiumOxybatePublicComment3 Mohammad Yunus, MD
FDA Public Comment 4 Evan Ekman, MD
Public Comment from August 20, 2010: Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee : The committees will discuss new drug application (NDA) 22-531, sodium oxybate, 375 milligrams per milliliter (mg/ml) oral solution, sponsored by Jazz Pharmaceuticals, with a proposed indication for the treatment of fibromyalgia for patients 18 years of age and older. The safety and efficacy findings for sodium oxybate in the fibromyalgia population and the proposed Risk Evaluation and Mitigation Strategy (REMS) for this product will be discussed. Release date: Aug 20, 2010
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