Lupin receives USFDA approval for Rufinamide Tablets

21 Aug 2022 , 01:33 AM

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 Inc The product will be manufactured at Lupins facility in Goa India Rufinamide Tablets RLD Banzel had estimated annual sales of USD 164 million in the US IQVIA MAT June 2022