Treats seizures associated with Lennox-Gastaut Syndrome. NDA 21911, held by Eisai Inc. Rufinamide.
As of Nov 14, 2026, NDA 21911 (Banzel), held by Eisai Inc, was first approved by FDA on Nov 14, 2008, with 9 approved supplements and 0 published complete response letters.
1 I NDICATIONS AND USAGE BANZEL is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 14, 2008 | Original applicationNew molecular entity · Standard review | Approved |
| Banzel100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Rufinamide | DiscontinuedReference drug |
| Banzel200MG · tablet;oral | Rufinamide | RxReference drug |
| Banzel400MG · tablet;oral | Rufinamide | RxReference drug |
| Nov 28, 2019 | Supplement 17Labeling · Standard review | Approved | |
| Jun 17, 2016 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Jun 25, 2015 | Supplement 13Labeling · Standard review | Approved | |
| Feb 12, 2015 | Supplement 12Labeling · Standard review | Approved | |
| Jun 6, 2013 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Jun 10, 2011 | Supplement 8REMS | Approved | |
| Mar 3, 2011 | Supplement 7REMS | Approved | |
| Nov 8, 2010 | Supplement 5Labeling · Standard review | Approved | |
| Oct 16, 2009 | Supplement 4Labeling · Standard review | Approved | |
| Nov 14, 2008 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
