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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: d6-tetrabenazine, deutetrabenazine
Trade Name: Austedo
Date Designated: 11/05/2014
Orphan Designation: Treatment of Huntington's Disease
Orphan Designation Status: Designated/Approved
Teva Branded Pharmaceutical Products R&D, Inc.
3333 N. Torrey Pines Court
Suite 400
La Jolla, California 92037
United States

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

Marketing approved:

1 Generic Name: d6-tetrabenazine, deutetrabenazine
Trade Name: Austedo
Marketing Approval Date: 04/03/2017
Approved Labeled Indication: Treatment of chorea associated with Huntington¿s disease
Exclusivity End Date: 04/03/2024 
Exclusivity Protected Indication* :  Treatment of chorea associated with Huntington¿s disease

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