Lupin today announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets, 5 mg/500 mg, 5 mg/1,000 mg, 10 mg/500 mg, 10 mg/1,000 mg. The company also received tentative approval for Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets, 2.5 mg/1,000 mg.

The U.S. FDA has approved Lupin's Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets as bioequivalent to Xigduo® XR for the indications in the approved labeling.