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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:  02/27/2014
Orphan Designation:  Treatment of Lennox-Gastaut syndrome
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  07/31/2020 
Approved Labeled Indication:  treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, 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 Lennox-Gastaut syndrome (LGS) in patients between 1 and 2 years of age
GW Research Ltd.
Sovereign House
Histon
Cambridge
United Kingdom

The sponsor address listed is the last reported by the sponsor to OOPD.
 
Generic Name:  cannabidiol
Trade Name:  Epidiolex
Date Designated:  02/27/2014
Orphan Designation:  Treatment of Lennox-Gastaut syndrome
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  09/28/2018 
Approved Labeled Indication:  EPIDIOLEX is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS) in patients 2 years of age and older.
Exclusivity End Date:    09/28/2025 
Exclusivity Protected Indication* :  EPIDIOLEX is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years 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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