Treats partial-onset seizures. ANDA 216461, held by Pharmazone. Lacosamide.
As of Nov 14, 2026, ANDA 216461 (Lacosamide), held by Pharmazone, was first approved by FDA on Feb 6, 2023, with 0 approved supplements and 0 published complete response letters.
Lacosamide oral solution 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 oral solution 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 oral solution 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 |
|---|---|---|---|
| Feb 6, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lacosamide10MG/ML · solution;oral | 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
