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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: deutetrabenazine
Date Designated: 01/13/2015
Orphan Designation: Treatment of Tourette syndrome in the pediatric population (defined as 0 through 16 years of age)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
TEVA Pharmaceuticals
3366 North Torrey Pines Court
Suite 225
LaJolla, California 92037
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.