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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: 6-fluoro-(18F)-L-3,4-dihydroxyphenylalanine
Date Designated: 09/07/2016
Orphan Designation: A diagnostic for management of patients with Lesch-Nyhan syndrome
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Advanced Imaging Projects, LLC
7947 Brookside Ct.
Lake Worth, Florida 33467
United States

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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