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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Topiramate
Trade Name: Topamax
Date Designated: 11/25/1992
Orphan Designation: Treatment of Lennox-Gastaut syndrome.
Orphan Designation Status: Designated/Approved
Johnson & Johnson Pharmaceutical R & D, LLC
Route 202, P.O. Box 300
Raritan, New Jersey 08869
United States

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

Marketing approved:

1 Generic Name: Topiramate
Trade Name: Topamax
Marketing Approval Date: 08/28/2001
Approved Labeled Indication: As adjunctive therapy in patients two years and older with siezures associated with Lennox-Gastaut syndrome.
Exclusivity End Date: 08/28/2008 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.