Treats seizures associated with Lennox-Gastaut Syndrome. ANDA 204993, held by Hetero Labs Ltd Iii. Rufinamide.
As of Nov 14, 2026, ANDA 204993 (Rufinamide), held by Hetero Labs Ltd Iii, was first approved by FDA on May 11, 2021, 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 |
|---|---|---|---|
| May 11, 2021 | 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
