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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Lamotrigine
Trade Name: Lamictal
Date Designated: 08/23/1995
Orphan Designation: Treatment of Lennox-Gastaut syndrome.
Orphan Designation Status: Designated/Approved
Glaxo Wellcome Research and Development
5 Moore Drive
P.O. Box 13398
Research Triangle Park, North Carolina 27709
United States

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

Marketing approved:

1 Generic Name: Lamotrigine
Trade Name: Lamictal
Marketing Approval Date: 08/24/1998
Approved Labeled Indication: Adjunctive treatment of Lennox-Gastaut syndrome in pediatric and adult patients.
Exclusivity End Date: 08/24/2005 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.