Search Orphan Drug Designations and Approvals
-
| Generic Name: | Topiramate | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Trade Name: | Topamax | ||||||||||||||||
| Date Designated: | 11/25/1992 | ||||||||||||||||
| Orphan Designation: | Treatment of Lennox-Gastaut syndrome. | ||||||||||||||||
| Orphan Designation Status: | Designated/Approved | ||||||||||||||||
| Sponsor: |
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* : | ||
-
