Lupin gets tentative approval from USFDA for Azilsartan Medoxomil Tablets

24 Dec 2021 Evaluate

Lupin has received tentative 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 Arbor Pharmaceuticals, LW. This product will be manufactured at Lupin's Nagpur facility in India.

Azilsartan Medoxomil Tablets (RLD: Edarbi Tablets) had estimated annual sales of $103.4 million in the U.S.

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India.

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