Lupin obtains tentative FDA approval for generic Canagliflozin Tablets

Global pharmaceutical leader, Lupin Limited, announced its significant achievement of receiving tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Canagliflozin Tablets, both 100 mg and 300 mg. This approval allows Lupin to market a generic equivalent of Invokana Tablets, manufactured by Janssen Pharmaceuticals, Inc., offering an advanced treatment option for individuals with type 2 diabetes.

Canagliflozin Tablets: A Step Forward in Diabetes Management

Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor, used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It also plays a crucial role in reducing the risk of major adverse cardiovascular events in diabetic patients with established cardiovascular disease and mitigating the risk of end-stage kidney disease and other complications.

Market Potential of Canagliflozin

The potential market for Canagliflozin Tablets is substantial, with the Reference Listed Drug (RLD) Invokana recording estimated annual sales of USD 561 million in the U.S., as per IQVIA MAT September 2023. Lupin’s entry into this market signifies a major development in affordable diabetes care.

Manufacturing and Global Impact

This product will be manufactured at Lupin’s state-of-the-art facility in Pithampur, India, exemplifying the company’s commitment to providing high-quality, affordable medication globally. This tentative approval by the FDA marks a pivotal moment for Lupin Limited in enhancing its portfolio in the diabetes care segment.