Lupin gets FDA approval for Vigabatrin for Oral Solution USP, 500 mg

Lupin Limited said that it has secured approval for Vigabatrin for Oral Solution USP, 500 mg, an anti-epileptic drug, from the US Food and Drug Administration (FDA).

The US pharma regulator approved the abbreviated new drug application (ANDA) of the Lupin product, which is a generic of Sabril for Oral Solution, 500 mg owned by Lundbeck Pharmaceuticals.

Lupin said that it will manufacture Vigabatrin for Oral Solution USP, 500 mg at its facility in Goa.

As per IQVIA MAT December 2021, Vigabatrin for Oral Solution USP, 500 mg had estimated sales of $275 million per year in the US.