Treats seizures associated with Lennox-Gastaut Syndrome. NDA 201367, held by Eisai Inc. Rufinamide.
As of Nov 13, 2026, NDA 201367 (Banzel), held by Eisai Inc, was first approved by FDA on Mar 3, 2011, with 7 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 |
|---|---|---|---|
| Feb 12, 2015 | Supplement 3Efficacy (new indication or use) · Priority review | Approved | |
| Mar 3, 2011 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Banzel40MG/ML · suspension;oral | Rufinamide | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 30, 2023 | Supplement 11Manufacturing · Standard review | Approved | |
| Nov 28, 2019 | Supplement 8Labeling · Standard review | Approved | |
| Oct 6, 2015 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Jun 25, 2015 | Supplement 5Labeling · Standard review | Approved | |
| Feb 12, 2015 | Supplement 3Efficacy (new indication or use) · Priority review | Approved | |
| Jan 5, 2015 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Jun 10, 2011 | Supplement 1REMS | Approved | |
| Mar 3, 2011 | Original applicationNew dosage form · 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
