Treats partial-onset seizures. ANDA 204857, held by Amneal Pharms. Lacosamide.
As of Nov 15, 2026, ANDA 204857 (Lacosamide), held by Amneal Pharms, was first approved by FDA on Mar 17, 2022, with 3 approved supplements and 0 published complete response letters.
Lacosamide tablets are 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 tablets are indicated for the treatment of partial-onset seizures in patients 4 years 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. Additional pediatric use information is approved for UCB, Inc.’s VIMPAT (lacosamide) tablets. However, due to UCB, Inc.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 17, 2022 | Original application | Approved |
| Lacosamide50MG · tablet;oral | Lacosamide | Discontinued |
| Lacosamide100MG · tablet;oral | Lacosamide | Discontinued |
| Lacosamide150MG · tablet;oral | Lacosamide | Discontinued |
| Lacosamide200MG · tablet;oral | Lacosamide | Discontinued |
| Sep 29, 2026 | Supplement 4Labeling · Standard review | Approved | None posted |
| Sep 29, 2026 | Supplement 8Labeling · Standard review | Approved | None posted |
| Sep 29, 2026 | Supplement 9Labeling · Standard review | Approved | None posted |
| Mar 17, 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
