Lupin Gets USFDA Approval for Xigduo XR Generic Dapagliflozin-Metformin Tablets
New Delhi: Lupin Limited has received approval from the United States Food and Drug Administration (USFDA) for its Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets in multiple strengths, strengthening its portfolio in the anti-diabetic segment.
The approval has been granted for strengths of 5 mg/500 mg, 5 mg/1000 mg, 10 mg/500 mg, and 10 mg/1000 mg under the company’s Abbreviated New Drug Application (ANDA). In addition, Lupin has also received tentative approval for the 2.5 mg/1000 mg strength of the combination drug.
The approved product is bioequivalent to the reference listed drug Xigduo XR, developed by AstraZeneca, and will be marketed in the United States for the approved indications.
Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets are used as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus, combining the benefits of an SGLT2 inhibitor and a widely used first-line anti-diabetic agent.
Lupin stated that the approval marks an important addition to its diabetes portfolio in the US market, where demand for combination therapies continues to grow.
Lupin Limited, headquartered in Mumbai, is a global pharmaceutical company with a presence in over 100 markets. The company offers a broad range of products including generics, complex generics, biotechnology products, and active pharmaceutical ingredients across key therapeutic areas such as cardiovascular, respiratory, anti-diabetic, and central nervous system disorders.
