Global pharma major Lupin Limited on Tuesday announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Dapagliflozin Tablets, 5 mg, and 10 mg.
Dapagliflozin is a medication used to treat type 2 diabetes.
The approval has been granted to market a generic equivalent of Farxiga Tablets, 5 mg, and 10 mg of AstraZeneca AB. This product will be manufactured at Lupin’s Pithampur facility in India.
Dapagliflozin Tablets (RLD Farxiga) had estimated annual sales of USD 7282 million in the U.S. (IQVIA MAT September 2023).