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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: [F18] florilglutamic acid
Date Designated: 07/13/2016
Orphan Designation: Diagnostic for the management of hepatocellular carcinoma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Life Molecular Imaging Ltd.
Iceni Centre, Warwick Technology Park
Warwick CV34 6DA
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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