Indian pharma major Lupin Limited has announced the launch of its Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets in the United States, marking another significant step in its expansion in the anti-diabetic segment.
The newly launched combination drug has received approval from the U.S. Food and Drug Administration (FDA) under the Abbreviated New Drug Application (ANDA) pathway. The product is therapeutically equivalent to Xigduo XR, a widely prescribed medication for managing type 2 diabetes.
Key Product Details
Lupin’s newly approved tablets will be available in multiple strengths, including:
- 5 mg/500 mg
- 5 mg/1,000 mg
- 10 mg/500 mg
- 10 mg/1,000 mg
These extended-release tablets are designed to help improve glycemic control in adults with type 2 diabetes, aligning with the approved labeling of the reference drug.
Strengthening Lupin’s U.S. Portfolio
The launch reinforces Lupin’s presence in the highly competitive U.S. generics market, particularly in the anti-diabetic therapy segment. By introducing a bioequivalent version of Xigduo XR, the company aims to provide a more affordable treatment option while maintaining the same efficacy and safety standards.