Search Orphan Drug Designations and Approvals
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Generic Name: | L-3,4-Dihydroxy-6-[18F]fluorophenylalanine |
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Date Designated: | 05/31/2017 |
Orphan Designation: | Diagnostic agent for the management of patients with aromatic L-amino acid decarboxylase deficiency (AADC). |
Orphan Designation Status: | Designated |
FDA Orphan Approval Status: | Not FDA Approved for Orphan Indication |
Sponsor: |
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. |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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