Lupin Limited has launched Dapagliflozin and Metformin Hydrochloride extended-release tablets in the United States in strengths of 5 mg/500 mg, 5 mg/1,000 mg, 10 mg/500 mg and 10 mg/1,000 mg.
The launch follows approval of the company’s Abbreviated New Drug Application (ANDA) by the United States Food and Drug Administration.
The product is approved as bioequivalent to Xigduo XR for the indications outlined in the reference drug’s labelling.