JZP-6 FDA Approval Status
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
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