Lacosamide Oral Solution

FDA Drug Profile — Lacosamide Oral Solution

Drug Details

Generic Name
Lacosamide Oral Solution
Brand Names
Lacosamide Oral Solution
Application Number
ANDA214672
Sponsor
Ascend Laboratories, LLC
NDC Codes
1
Dosage Forms
SOLUTION
Routes
ORAL
Active Ingredients
LACOSAMIDE

Indications and Usage

1 INDICATIONS AND USAGE Lacosamide oral solution 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 oral solution is indicated for the treatment of partial-onset seizures in patients 4 years 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. Additional pediatric use information is approved for UCB, Inc.’s VIMPAT ® (lacosamide) oral solution. However, due to UCB, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.