Zydus receives USFDA approval for Vigabatrin for Oral Solution

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Vigabatrin for Oral Solution USP, 500 mg (USRLD: Sabril for Oral Solution).

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. It is also used to treat infantile spasms in babies and children between the ages of 1 month and 2 years. The drug will be manufactured at the group's formulation manufacturing facility at Moraiya, Ahmedabad (India).

Vigabatrin for Oral Solution USP, 500 mg had annual sales of USD 233.7 mn in the United States (IQVIA MAT Dec. 2022).

Powered by Capital Market - Live News