Treats seizures associated with Lennox-Gastaut Syndrome. ANDA 216688, held by Micro Labs. Rufinamide.
As of Nov 14, 2026, ANDA 216688 (Rufinamide), held by Micro Labs, was first approved by FDA on May 15, 2023, with 0 approved supplements and 0 published complete response letters.
Rufinamide tablet is 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 |
|---|---|---|---|
| May 15, 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
