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JZP-6 FDA Approval Status

Last updated by Judith Stewart, BPharm on Jan 30, 2020.

FDA Approved: No
Brand name: JZP-6
Generic name: sodium oxybate
Dosage form: Oral Solution
Company: Jazz Pharmaceuticals plc
Treatment for: Fibromyalgia

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

In October 2010, Jazz Pharmaceuticals, Inc. announced the receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) advising the company that the New Drug Application (NDA) for JZP-6 had not been approved.

Development timeline 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

Further information

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