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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
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* :  
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.