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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 oral solution (CBD-OS)
Date Designated: 06/07/2021
Orphan Designation: Treatment of epilepsy with myoclonic-atonic seizures
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
GW Research Ltd
5750 Fleet Street Suite 200
Sovereign House
Histon, Cambridge CB24 9BZ
United Kingdom

The sponsor address listed is the last reported by the sponsor to OOPD.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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