Zydus gets final US FDA approval for Vigabatrin for Oral Solution USP, 500 mg

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 two years of age and older. It is also used to treat infantile spasms in babies and children between the ages of one month and two 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 $ 233.7 million in the United States (IQVIA MAT Dec. 2022).

The group now has 349 approvals and has so far filed over 440* ANDAs since the commencement of the filing process in FY 2003-04.