Lupin receives USFDA approval for Azilsartan Medoxomil Tablets

Lupin announced that it has received tentative 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 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 USD 103.4 million in the U.S. (IQVIA MAT September 2021).

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