JZP-6 Approval Status

  • FDA approved: No
  • Brand name: JZP-6
  • Generic name: sodium oxybate
  • Company: Jazz Pharmaceuticals, Inc.
  • Treatment for: Fibromyalgia

JZP-6 (sodium oxybate oral solution) is a central nervous system depressant in development for the treatment of fibromyalgia.

FDA Approval Status for JZP-6

DateArticle
Oct 11, 2010Jazz Pharmaceuticals Receives FDA Complete Response Letter Regarding JZP-6 for Treatment of Fibromyalgia
Aug 23, 2010Jazz Pharmaceuticals Provides Update on FDA Advisory Committee Meeting For JZP-6 (Sodium Oxybate) in Fibromyalgia
Jun 25, 2010Jazz Pharmaceuticals' JZP-6 to be Reviewed at a Joint Meeting of the FDA's Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee on August 20, 2010
Feb 19, 2010Jazz Pharmaceuticals Announces FDA Acceptance of its New Drug Application for JZP-6 (sodium oxybate) for the Treatment of Fibromyalgia
Dec 15, 2009Jazz Pharmaceuticals Submits New Drug Application for JZP-6 (sodium oxybate) for the Treatment of Fibromyalgia

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