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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: delta-9-tetrahydrocannibinol and cannabidiol
Date Designated: 12/03/2015
Orphan Designation: Treatment of glioma.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Jazz Pharmaceuticals Research UK Limited
Building 730, Kent Science Park
Sittingbourne
Kent ME9 8AG
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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