Zydus receives USFDA approval for Vigabatrin for Oral Solution

The United States Food and Drug Administration (USFDA) has granted final approval to Zydus Lifesciences for Vigabatrin for Oral Solution USP, 500 mg (USRLD: Sabril for Oral Solution).
Vigabatrin for oral solution is indicated as adjunctive therapy in patients 2 years of age and older with refractory complex partial seizures. It is also used to treat infantile spasms in babies and children aged one month to two years. The medication will be produced at the group’s formulation manufacturing facility in Moraiya, Ahmedabad (India). In the United States, Vigabatrin for Oral Solution USP, 500 mg had annual sales of USD 233.7 million (IQVIA MAT Dec. 2022).