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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: fluciclovine (18F)(anti-1-amino-3-fluorocyclobutane-1-carboxylic acid, labelled with Fluorine-18)
Date Designated: 04/07/2015
Orphan Designation: For the diagnosis of glioma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Blue Earth Diagnostics Ltd.
215 Euston Rd.
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.