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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 HCI
Trade Name: Fintepla
Date Designated: 12/20/2013
Orphan Designation: For the Treatment of Dravet Syndrome
Orphan Designation Status: Designated/Approved
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.

Marketing approved:

1 Generic Name: fenfluramine HCI
Trade Name: Fintepla
Marketing Approval Date: 06/25/2020
Approved Labeled Indication: Fintepla (fenfluramine) is indicated for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older.
Exclusivity End Date: 06/25/2027 
Exclusivity Protected Indication* :  For the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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