Lupin receives tentative approval for Empagliflozin tablets

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An innovation-led transnational pharmaceutical company headquartered in Mumbai, Lupin Limited (Lupin) has recently announced that it has received tentative approval for its Empagliflozin Tablets, 10 mg, and 25 mg, from the United States Food and Drug Administration (U.S. FDA) to market a generic version of Jardiance® Tablets, 10 mg, and 25 mg, of Boehringer Ingelheim Pharmaceuticals, Inc.

Empagliflozin Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Empagliflozin Tablets, 10 mg and 25 mg (RLD: Jardiance®) had an annual sale of approximately USD 4,368 million in the U.S. (IQVIA MAT Mar 2020).