Lupin Dapagliflozin Tablets gets tentative USFDA okay

Mumbai: Global pharma major Lupin Limited has announced that the Company has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Dapagliflozin Tablets, 5 mg, and 10 mg to market a generic equivalent of Farxiga Tablets, 5 mg, and 10 mg of AstraZeneca AB. Dapagliflozin Tablets are used for the treatment of type 2 diabetes.

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

Dapagliflozin Tablets (RLD Farxiga) had estimated annual sales of USD 7282 million in the U.S. (IQVIA MAT September 2023).

Read also: Lupin gets USFDA approval for Ganirelix Acetate Injection

Medical Dialogues team had earlier reported that Lupin had received tentative approval from the USFDA for its Abbreviated New Drug Application for Canagliflozin and Metformin Hydrochloride Extended-Release Tablets, 50 mg/500 mg, 50 mg/1,000 mg, 150 mg/500 mg, and 150 mg/1,000 mg to market a generic equivalent of Invokamet XR Tablets, 50 mg/500 mg, 50 mg/1,000 mg, 150 mg/500 mg, and 150 mg/1,000 mg, of Janssen Pharmaceuticals, Inc.

Read also: Lupin gets tentative USFDA nod for Canagliflozin, Metformin Hydrochloride ER tablets

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 gets USFDA nod for cholesterol lowering drug Pitavastatin