Treats partial-onset seizures. ANDA 219699, held by Ajenat Pharms. Lacosamide.
As of Nov 14, 2026, ANDA 219699 (Lacosamide), held by Ajenat Pharms, was first approved by FDA on Jun 26, 2025, 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 |
|---|---|---|---|
| Jun 26, 2025 | 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
