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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: tasimelteon
Trade Name: HETLIOZ
Date Designated: 01/19/2010
Orphan Designation: Non-24-hour sleepwake disorder in blind individuals without light perception
Orphan Designation Status: Designated/Approved
Vanda Pharmaceuticals, Inc.
2200 Penn. Ave., NW
Suite 300 E
Washington, District of Columbia 20037
United States

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

Marketing approved:

1 Generic Name: tasimelteon
Trade Name: HETLIOZ
Marketing Approval Date: 01/31/2014
Approved Labeled Indication: Treatment of non-24-hour sleep-wake disorder
Exclusivity End Date: 01/31/2021 
Exclusivity Protected Indication* :  Treatment of non-24-hour sleep-wake disorder
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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