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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 LQ
Date Designated:  04/30/2010
Orphan Designation:  Treatment of the sleep disorder in Smith-Magenis syndrome associated with diurnal melatonin secretion.
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  12/01/2020 
Approved Labeled Indication:  Treatment of nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in pediatric patients 3 to 15 years of age
Exclusivity End Date:    12/01/2027 
Exclusivity Protected Indication* :  Treatment of nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in pediatric patients 3 to 15 years of age
Vanda Pharmaceuticals, Inc.
9605 Medical Center Drive
Rockville, Maryland 20850
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
 
Generic Name:  tasimelteon
Trade Name:  Hetlioz
Date Designated:  04/30/2010
Orphan Designation:  Treatment of the sleep disorder in Smith-Magenis syndrome associated with diurnal melatonin secretion.
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  12/01/2020 
Approved Labeled Indication:  Treatment of nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older
Exclusivity End Date:    12/01/2027 
Exclusivity Protected Indication* :  Treatment of nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older.
Vanda Pharmaceuticals, Inc.
9605 Medical Center Drive
Rockville, Maryland 20850
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.
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