Lupin type 2 diabetes drug Canagliflozin bags USFDA tentative approval

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 Canagliflozin Tablets, 100 mg and 300 mg, to market a generic equivalent of Invokana Tablets, 100 mg and 300 mg, of Janssen Pharmaceuticals, Inc.

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

Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated:

 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

 to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease

 to reduce the risk of end-stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria

Canagliflozin Tablets (RLD Invokana) had estimated annual sales of USD 561 million in the U.S. (IQVIA MAT September 2023).

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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.

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