Treats partial-onset seizures. ANDA 209224, held by Aurobindo Pharma Ltd. Lacosamide.
As of Nov 14, 2026, ANDA 209224 (Lacosamide), held by Aurobindo Pharma Ltd, was first approved by FDA on Jan 24, 2024, with 2 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 |
|---|---|---|---|
| Jan 24, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lacosamide10MG/ML · solution;oral | Lacosamide | Rx |
| May 22, 2026 | Supplement 2Labeling · Standard review | Approved | None posted |
| Nov 15, 2024 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jan 24, 2024 | 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
