Treats seizures associated with Lennox-Gastaut Syndrome. ANDA 205075, held by Glenmark Pharms Ltd. Rufinamide.
As of Nov 14, 2026, ANDA 205075 (Rufinamide), held by Glenmark Pharms Ltd, was first approved by FDA on May 16, 2016, with 1 approved supplement 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 16, 2016 | Original application | Approved |
| Rufinamide200MG · tablet;oral | Rufinamide | Rx |
| Rufinamide400MG · tablet;oral | Rufinamide | Rx |
| Mar 10, 2022 | Supplement 1Labeling · Standard review | Approved | None posted |
| May 16, 2016 | Original application | 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
