Lupin gets tentative nod for Empagliflozin and Linagliptin tablets

Lupin announced that it has received tentative approval for its Empagliflozin and Linagliptin Tablets, from the USFDA to market a generic version of Glyxambi Tablets of Boehringer Ingelheim Pharmaceuticals, Inc.

The announcement was made after market hours yesterday, 23 July 2020. Shares of Lupin settled 1.37% higher at Rs 862.85 yesterday.

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 (U.S. 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 had an annual sales of approximately $242 million in the U.S. (IQVIA MAT March 2020).

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai. The company develops and commercializes a wide range of branded and generic formulations, biotechnology products and APIs in over 100 markets in the U.S., India, South Africa and across Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.

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