Treats partial-onset seizures. ANDA 214672, held by Alkem Labs Ltd. Lacosamide.
As of Nov 14, 2026, ANDA 214672 (Lacosamide), held by Alkem Labs Ltd, was first approved by FDA on May 19, 2022, with 1 approved supplement and 0 published complete response letters.
Lacosamide oral solution is indicated for: Treatment of partial-onset seizures in patients 4 years 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 4 years 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. Additional pediatric use information is approved for UCB, Inc.’s VIMPAT (lacosamide) oral solution.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 19, 2022 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lacosamide10MG/ML · solution;oral | Lacosamide | Rx |
| Mar 28, 2023 | Supplement 1Labeling · Standard review | Approved | None posted |
| May 19, 2022 | Original application | Approved |
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
