Treats partial-onset seizures. ANDA 205031, held by Sun Pharm. Lacosamide.
As of Nov 14, 2026, ANDA 205031 (Lacosamide), held by Sun Pharm, was first approved by FDA on Mar 17, 2022, with 4 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 tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older. 1.2 Primary Generalized Tonic-Clonic Seizures Lacosamide tablets are 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 |
|---|---|---|---|
| Mar 17, 2022 | Original application | Approved | None posted |
| Lacosamide50MG · tablet;oral | Lacosamide | Rx |
| Lacosamide100MG · tablet;oral | Lacosamide | Rx |
| Lacosamide150MG · tablet;oral | Lacosamide | Rx |
| Lacosamide200MG · tablet;oral | Lacosamide | Rx |
| Nov 15, 2024 | Supplement 2Labeling · Standard review | Approved | None posted |
| Nov 15, 2024 | Supplement 3Labeling · Standard review | Approved | None posted |
| Nov 15, 2024 | Supplement 5Labeling · Standard review | Approved | None posted |
| Nov 15, 2024 | Supplement 10Labeling · Standard review | Approved | None posted |
| Mar 17, 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
