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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Tetrabenazine
Date Designated: 05/12/1998
Orphan Designation: Treatment of moderate/severe tardive dyskinesia.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Prestwick Pharmaceuticals, Inc.
1825 K Street, NW
Suite 1475
Washington, District of Columbia 20006
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.