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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
Date Designated: 07/14/2015
Orphan Designation: Prevention of Graft versus Host Disease (GVHD).
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Kalytera Therapeutics Israel, Ltd.
Technological Building
Road 4 Katzrin
Qatsrin
Israel

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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