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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Felbamate
Trade Name: Felbatol
Date Designated: 01/24/1989
Orphan Designation: Treatment of Lennox-Gastaut syndrome.
Orphan Designation Status: Designated/Approved
Wallace Laboratories
301B College Road East
Princeton, New Jersey 08540
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: Felbamate
Trade Name: Felbatol
Marketing Approval Date: 07/29/1993
Approved Labeled Indication: As adjunctive therapy in the treatment of partial and generalized seizures associated with the Lennox-Gastaut syndrome in children.
Exclusivity End Date: 07/29/2000 
Exclusivity Protected Indication* :  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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