Treats partial-onset seizures. ANDA 218706, held by Op Nanopharma. Lacosamide.
As of Nov 14, 2026, ANDA 218706 (Lacosamide), held by Op Nanopharma, was first approved by FDA on May 23, 2025, 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 |
|---|---|---|---|
| May 23, 2025 | 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
