lacosamide
Drug Details
- Generic Name
- lacosamide
- Brand Names
- MOTPOLY XR, lacosamide, Lacosamide, Vimpat
- Application Number
- NDA216185
- Sponsor
- Aucta Pharmaceuticals, Inc.
- NDC Codes
- 41
- Dosage Forms
- CAPSULE, EXTENDED RELEASE, POWDER, TABLET, FILM COATED, INJECTION, SOLUTION, INJECTION, SOLUTION
- Routes
- ORAL, INTRAVENOUS
- Active Ingredients
- LACOSAMIDE
Indications and Usage
1 INDICATIONS AND USAGE Lacosamide injection is 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 injection is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. Pediatric use information is approved for UCB, Inc.’s VIMPAT ® (lacosamide) injection. 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 injection is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older.