Lupin receives approval from USFDA for hypertension tablets

Lupin Limited 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. Azilsartan is used to treat high blood pressure (hypertension).

 Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems.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 US.