Treats seizures associated with Lennox-Gastaut Syndrome. ANDA 216841, held by Hetero Labs Ltd Iii. Rufinamide.
As of Nov 14, 2026, ANDA 216841 (Rufinamide), held by Hetero Labs Ltd Iii, was first approved by FDA on Dec 5, 2023, 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 |
|---|---|---|---|
| Dec 5, 2023 | 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
