Treats partial-onset seizures. ANDA 218464, held by Acella. Lacosamide.
As of Nov 14, 2026, ANDA 218464 (Lacosamide), held by Acella, was first approved by FDA on Nov 14, 2024, with 0 approved supplements and 0 published complete response letters.
Lacosamide is indicated for: Treatment of partial-onset seizures in patients 1 month 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 is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. 1.2 Primary Generalized Tonic-Clonic Seizures Lacosamide is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 14, 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
