Zydus Lifesciences gets FDA final approval for Vigabatrin for Oral Solution

Zydus Lifesciences has bagged final approval for seizures drug Vigabatrin for Oral Solution USP, 500 mg from the US Food and Drug Administration (FDA).

Vigabatrin for Oral Solution is a generic version of Sabril for Oral Solution.

It is approved to treat refractory complex partial seizures as adjunctive therapy in patients aged two years and older. Besides, Vigabatrin for Oral Solution is indicated for the treatment of infantile spasms in babies and children between one month and two years.

Zydus Lifesciences will manufacture the seizures drug at its formulation manufacturing facility in Moraiya, Ahmedabad.

As per QVIA MAT December 2022, the annual sales of Vigabatrin for Oral Solution USP, 500 mg in the US was $233.7m.