Search Orphan Drug Designations and Approvals
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| Generic Name: | Tetrabenazine | ||||||||||||||||
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| Trade Name: | Xenazine | ||||||||||||||||
| Date Designated: | 12/11/1997 | ||||||||||||||||
| Orphan Designation: | Treatment of Huntington's disease | ||||||||||||||||
| Orphan Designation Status: | Designated/Approved | ||||||||||||||||
| Sponsor: |
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. |
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Marketing approved: |
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| 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* : | ||
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