Lupin bags tentative USFDA nod for Dapagliflozin and Saxagliptin Tablets

Mumbai: Global pharma major Lupin Limited has announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Dapagliflozin and Saxagliptin Tablets, 5 mg/5 mg and 10 mg/5 mg, to market a generic equivalent of Qtern Tablets, 5 mg/5 mg and 10 mg/5 mg of AstraZeneca AB.

This product will be manufactured at Lupin’s Pithampur facility in India.

Dapagliflozin and Saxagliptin Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin and Saxagliptin Tablets (RLD Qtern) had estimated annual sales of USD 5 million in the U.S. (IQVIA MAT November 2023).

Medical Dialogues team had earlier reported that Lupin had received tentative approval from the U.S. FDA for its Abbreviated New Drug Application (ANDA), Sitagliptin Tablets USP, 25 mg, 50 mg, and 100 mg to market a generic equivalent of Januvia Tablets, 25 mg, 50 mg, and 100 mg, of Merck Sharp and Dohme Corp.

Read also: USFDA gives tentative nod for Lupin diabetes drug Sitagliptin

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. 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 the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas.

Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions. The company invested 7.9% of its revenue in research and development in FY23. Lupin has 15 manufacturing sites, 7 research centers.

Read also: Lupin Launches Dapaturn GM Range for Improved Approach to Manage Type 2 Diabetes