Treats seizures associated with Lennox-Gastaut Syndrome. ANDA 207363, held by Hikma. Rufinamide.
As of Nov 14, 2026, ANDA 207363 (Rufinamide), held by Hikma, was first approved by FDA on Apr 23, 2019, with 1 approved supplement and 0 published complete response letters.
Rufinamide 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 |
|---|---|---|---|
| Apr 23, 2019 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Rufinamide40MG/ML · suspension;oral | Rufinamide | Rx |
| Aug 7, 2020 | Supplement 1Labeling · Standard review | Approved | None posted |
| Apr 23, 2019 | 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
