Search Orphan Drug Designations and Approvals
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Generic Name: | 1-(2-Nitro-imidazolyl)-3-[18F]fluoro-2-propanol; 1H-1-(3-[18F]fluoro-2-hydroxypropyl0-2-nitroimidazole (18F-Misonidazole) |
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Date Designated: | 04/06/2016 |
Orphan Designation: | Diagnostic for management of glioma. |
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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