Treats seizures associated with Lennox-Gastaut Syndrome. ANDA 217230, held by Aurobindo Pharma. Rufinamide.
As of Nov 14, 2026, ANDA 217230 (Rufinamide), held by Aurobindo Pharma, was first approved by FDA on Jun 16, 2023, with 0 approved supplements and 0 published complete response letters.
Rufinamide tablets are indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 16, 2023 | Original application | Approved | None posted |
| Rufinamide200MG · tablet;oral | Rufinamide | Rx |
| Rufinamide400MG · tablet;oral | Rufinamide | Rx |
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
