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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
Trade Name: Xenazine
Date Designated: 12/11/1997
Orphan Designation: Treatment of Huntington's disease
Orphan Designation Status: Designated/Approved
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.

Marketing approved:

1 Generic Name: Tetrabenazine
Trade Name: Xenazine
Marketing Approval Date: 08/15/2008
Approved Labeled Indication: Treatment of chorea associated with Huntington's disease
Exclusivity End Date: 08/15/2015 
Exclusivity Protected Indication* :  

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