Express Pharma

Lupin receives US FDA’s tentative approval for Empagliflozin and Linagliptin Tablets

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

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Pharma major Lupin announced that it has received tentative approval for its Empagliflozin and Linagliptin Tablets, 10 mg/5 mg and 25 mg/5 mg, from the United States Food and Drug Administration (US FDA) to market a generic version of Glyxambi Tablets, 10 mg/5 mg and 25 mg/5 mg, of Boehringer Ingelheim Pharmaceuticals, Inc.

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

Empagliflozin and Linagliptin Tablets, 10 mg/5 mg and 25 mg/5 mg (RLD: Glyxambi®) had an annual sales of approximately USD 242 million in the U.S. (IQVIA MAT Mar 2020).

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