vigabatrin

FDA Drug Profile — SABRIL, vigabatrin, vigabatrin for oral solution, VIGPODER, Vigabatrin

Drug Details

Generic Name
vigabatrin
Brand Names
SABRIL, vigabatrin, vigabatrin for oral solution, VIGPODER, Vigabatrin, VIGABATRIN, VIGAFYDE, VIGADRONE
Application Number
NDA022006
Sponsor
Lundbeck Pharmaceuticals LLC
NDC Codes
15
Dosage Forms
POWDER, FOR SOLUTION, TABLET, FILM COATED, FOR SOLUTION, SOLUTION
Routes
ORAL
Active Ingredients
VIGABATRIN

Indications and Usage

1 INDICATIONS AND USAGE Vigabatrin for oral solution is indicated for the treatment of: Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older who have responded inadequately to several alternative treatments; vigabatrin for oral solution is not indicated as a first line agent (1.1) Infantile Spasms - monotherapy in infants 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss (1.2) 1.1 Refractory Complex Partial Seizures (CPS) Vigabatrin for oral solution is indicated as adjunctive therapy for adults and pediatric patients 2 years of age and older with refractory complex partial seizures who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss [see Warnings and Precautions (5.1) ] . Vigabatrin for oral solution is not indicated as a first line agent for complex partial seizures. 1.2 Infantile Spasms (IS) Vigabatrin for oral solution is indicated as monotherapy for pediatric patients with infantile spasms 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss [see Warnings and Precautions (5.1) ] .