The FDA has given Lupin tentative approval for Azilsartan Medoxomil Tablets

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Lupin Limited (Lupin) today announced that the United States Food and Drug Administration (FDA) has tentatively approved its Abbreviated New Drug Application (ANDA) Azilsartan Medoxomil Tablets, 40 mg, and 80 mg to market a generic equivalent of Arbor Pharmaceuticals, LLC’s Edarbi® Tablets, 40 mg, and 80 mg. Lupin’s Nagpur factory in India will manufacture this product.

In the United States, Azilsartan Medoxomil Tablets (RLD: Edarbi Tablets) had yearly sales of USD 103.4 million (IQVIA MAT September 2021).

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