• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

  • Print
  • Share
  • E-mail
-
Generic Name: fenfluramine
Trade Name: Fintepla
Date Designated: 06/19/2017
Orphan Designation: Treatment of Lennox-Gastaut 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
Trade Name: Fintepla
Marketing Approval Date: 03/25/2022
Approved Labeled Indication: Treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age and older
Exclusivity End Date: 03/25/2029 
Exclusivity Protected Indication* :  Treatment of seizures associated with Lennox-Gastaut syndrome (LGS) 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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-