Lupin has announced the launch of dapagliflozin and metformin hydrochloride extended-release tablets in the United States, following approval of its Abbreviated New Drug Application (ANDA) by the U.S. Food and Drug Administration.

The newly launched medication is available in multiple strengths, including 5 mg/500 mg, 5 mg/1000 mg, 10 mg/500 mg and 10 mg/1000 mg. The formulation has been approved as bioequivalent to Xigduo XR and will be used for the same indications as outlined in the reference product’s labelling.

The combination therapy is commonly prescribed for the management of type 2 diabetes, combining the benefits of dapagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, and metformin, a widely used first-line treatment. The extended-release formulation allows for improved patient compliance through convenient dosing.

With this launch, Lupin aims to expand its presence in the US diabetes care market while providing cost-effective alternatives to branded medications.

Headquartered in Mumbai, Lupin is a global pharmaceutical company with operations in over 100 markets. The company’s portfolio includes branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.