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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: flubrobenguane (18F)
Date Designated: 06/04/2019
Orphan Designation: Diagnostic for the management of neuroendocrine tumors
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 11/06/2024
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Lantheus Medical Imaging, Inc.
331 Treble Cove Road
North Billerica, Massachusetts 01862
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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