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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: fenfluramine hydrochloride
Date Designated: 06/07/2022
Orphan Designation: Treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
UCB, Inc.
1950 Lake Park Drive, Bldg 2100
Smyrna, Georgia 30080
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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