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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
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* :  
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.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.