Treats seizures associated with Lennox-Gastaut Syndrome. ANDA 216549, held by Aurobindo Pharma. Rufinamide.
As of Nov 14, 2026, ANDA 216549 (Rufinamide), held by Aurobindo Pharma, was first approved by FDA on Oct 26, 2022, with 0 approved supplements 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 |
|---|---|---|---|
| Oct 26, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Rufinamide40MG/ML · suspension;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
