Lupin Receives FDA Approval for Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets in the United States

Global pharma major Lupin Limited has 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. The approval includes four strengths: 5 mg/500 mg, 5 mg/1,000 mg, 10 mg/500 mg, and 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. Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. The company specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.