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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: florbetaben F18
Date Designated: 04/07/2020
Orphan Designation: Diagnostic for the management of amyloid light chain (AL) amyloidosis
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Life Molecular Imaging Ltd.
First Floor, The Woods, Opus 40 Business Park
Warwick CV34 5AH
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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