USFDA approves Lupin’s Vigabatrin oral solution

The product will be manufactured at Lupin’s facility in Goa, India

Lupin announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Vigabatrin for Oral Solution USP, 500 mg to market a generic equivalent of Sabril for Oral Solution, 500 mg of Lundbeck Pharmaceuticals, LLC. The product will be manufactured at Lupin’s facility in Goa, India.  

Vigabatrin for Oral Solution USP, 500 mg (RLD Sabril) had estimated annual sales of US $ 275 million in the U.S. (IQVIA MAT December 2021).