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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  cannabidiol
Trade Name:  Epidiolex
Date Designated:  04/19/2016
Orphan Designation:  Treatment of tuberous sclerosis complex.
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  07/31/2020 
Approved Labeled Indication:  treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in patients 1 year of age and older
Exclusivity End Date:    07/31/2027 
Exclusivity Protected Indication* :   treatment of seizures associated with tuberous sclerosis complex (TSC) in patients 1 year of age and older
GW Research Ltd.
Sovereign House
Histon
Cambridge
United Kingdom

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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