Search Orphan Drug Designations and Approvals
-
Generic Name: | Lamotrigine | ||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Trade Name: | Lamictal | ||||||||||||||||
Date Designated: | 08/23/1995 | ||||||||||||||||
Orphan Designation: | Treatment of Lennox-Gastaut syndrome. | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
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* : | ||
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-