Lupin gets approval from US FDA for Azilsartan Medoxomil Tablets
The product will be manufactured at Lupin’s facility in Nagpur, India.
Lupin 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. The product will be manufactured at Lupin’s facility in Nagpur, India.
Azilsartan Medoxomil Tablets (RLD Edarbi) had estimated annual sales of $101 million in the US (IQVIA MAT March 2022).