lacosamide
Drug Details
- Generic Name
- lacosamide
- Brand Names
- MOTPOLY XR, Lacosamide, Vimpat, lacosamide
- Application Number
- NDA216185
- Sponsor
- Aucta Pharmaceuticals, Inc.
- NDC Codes
- 41
- Dosage Forms
- CAPSULE, EXTENDED RELEASE, INJECTION, SOLUTION, INJECTION, SOLUTION, TABLET, FILM COATED, POWDER
- Routes
- ORAL, INTRAVENOUS
- Active Ingredients
- LACOSAMIDE
Indications and Usage
1 INDICATIONS AND USAGE Lacosamide tablets are indicated for: • Treatment of partial-onset seizures in patients 4 years of age and older (1.1) • Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older (1.2) 1.1 Partial-Onset Seizures Lacosamide tablets are indicated for the treatment of partial-onset 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.’s marketing exclusivity rights, this drug product is not labeled with that information. 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.