vigabatrin
vigabatrin is listed in the FDA National Drug Code directory with 14 NDC codes, marketed under brand names including vigabatrin, SABRIL, vigabatrin for oral solution. Available dosage forms: powder, for solution, tablet, film coated, for solution, solution.
Drug Details
- Generic Name
- vigabatrin
- Brand Names
- vigabatrin, SABRIL, vigabatrin for oral solution, VIGABATRIN, Vigabatrin, VIGAFYDE, VIGADRONE
- Application Number
- ANDA214671
- Sponsor
- Zydus Pharmaceuticals (USA) Inc.
- NDC Codes
- 14
- 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 )].
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 )].