Lupin gets USFDA’s approval for Azilsartan Medoxomil Tablets

25 Jul 2022 Evaluate

Lupin has received approval from the United States Food and Drug Administration (USFDA) 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 $101 million in the U.S. (IQVIA MAT March 2022).

Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.

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