Treats partial-onset seizures. ANDA 216151, held by Novitium Pharma. Lacosamide.
As of Nov 14, 2026, ANDA 216151 (Lacosamide), held by Novitium Pharma, was first approved by FDA on Aug 26, 2022, with 2 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 |
|---|---|---|---|
| Aug 26, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lacosamide10MG/ML · solution;oral | Lacosamide | Rx |
| Jul 21, 2023 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jul 21, 2023 | Supplement 4Labeling · Standard review | Approved | None posted |
| Aug 26, 2022 | Original application | Approved | None posted |
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
