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Lupin gets tentative nod from USFDA to market type 2 diabetes drug

Drug firm Lupin on Thursday said it has received tentative nod from the US health regulator to market generic Empagliflozin and Linagliptin tablets, used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

The product is a generic version of Boehringer Ingelheim Pharmaceuticals Inc”s Glyxambi tablets in the same strengths, Lupin said in a statement.

The company has received tentative approval to market Empagliflozin and Linagliptin tablets in the strengths of 10 mg/5 mg and 25 mg/5 mg, from the United States Food and Drug Administration (USFDA), it added.

According to IQVIA MAT March 2020 data, Empagliflozin and Linagliptin tablets, 10 mg/5 mg and 25 mg/5 mg had an annual sales of approximately USD 242 million in the US.

The tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, it informed.

Shares of Lupin Ltd closed at Rs 862.85 per scrip on the BSE, up 1.37 per cent from its previous close. – PTI

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