Lupin receives approval from U.S. FDA for Azilsartan Medoxomil Tablets

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

Global pharma major 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), Azilsartan Medoxomil Tablets, 40 mg and 80 mg, to market a generic equivalent of Edarbi® Tablets, 40 mg and 80 mg, of Azurity Pharmaceuticals, Inc. The product will be manufactured at Lupin's facility in Nagpur, India.

Azilsartan Medoxomil Tablets (RLD Edarbi) had estimated annual sales of USD 101 million in the U.S. (IQVIA MAT March 2022).