Treats partial-onset seizures. ANDA 214960, held by Somerset Theraps LLC. Lacosamide.
As of Nov 14, 2026, ANDA 214960 (Lacosamide), held by Somerset Theraps LLC, was first approved by FDA on Oct 9, 2024, with 0 approved supplements and 0 published complete response letters.
Lacosamide injection is indicated for: Treatment of partial-onset seizures in patients 4 years of age and older Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older 1.1 Partial-Onset Seizures Lacosamide injection is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. Pediatric use information is approved for UCB, Inc.'s VIMPAT (lacosamide) injection. However, due to UCB, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 9, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lacosamide200MG/20ML (10MG/ML) · solution;intravenous | Lacosamide | 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
