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FDA gives Lupin tentative nod for generic Glyxambi


Patients with Type 2 diabetes will soon have a new generic medication.

Lupin has received the Food and Drug Administration’s tentative nod for empagliflozin and linagliptin tablets, in dosage strengths of 10 mg/5 mg and 25 mg/5 mg.

The product is the generic of Boehringer Ingelheim's Glyxambi tablets, 10 mg/5 mg and 25 mg/5 mg.

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

The product had a market value of approximately $242 million, according to IQVIA March 2020 data.

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