Treats seizures associated with Lennox-Gastaut Syndrome. ANDA 213410, held by Alkem Labs Ltd. Rufinamide.
As of Nov 14, 2026, ANDA 213410 (Rufinamide), held by Alkem Labs Ltd, was first approved by FDA on Feb 23, 2021, with 1 approved supplement and 0 published complete response letters.
Rufinamide oral suspension 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 |
|---|---|---|---|
| Feb 23, 2021 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Rufinamide40MG/ML · suspension;oral | Rufinamide | Rx |
| Jun 3, 2024 | Supplement 2Labeling · Standard review | Approved | None posted |
| Feb 23, 2021 | Original application | Approved | None posted |
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
