Lupin receives approval from U.S. FDA for Rufinamide Tablets USP

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

Lupin Limited (Lupin) announced that it 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, India.

Rufinamide Tablets (RLD Banzel®) had estimated annual sales of USD 164 million in the U.S. (IQVIA MAT June 2022).