Lupin receives approval from US FDA for Rufinamide tabs USP

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

Lupin has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Rufinamide Tablets USP, 100 mg, 200 mg, and 400 mg, to market a generic equivalent of Banzel Tablets, 100 mg, 200 mg, and 400 mg, of Eisai. The product will be manufactured at Lupin’s facility in Goa.

Rufinamide Tablets (RLD Banzel) had estimated annual sales of $164 million in the US (IQVIA MAT June 2022).