USFDA grants tentative approval to Lupin’s generic formulation for type 2 diabetes

USFDA grants tentative approval to Lupin’s generic formulation for type 2 diabetes

Global pharma major Lupin Limited on Friday 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 and Saxagliptin Tablets, 5 mg/5 mg and 10 mg/5 mg.

According to the company’s press statement, the approval has been granted to market a generic equivalent of Qtern Tablets, 5 mg/5 mg and 10 mg/5 mg of AstraZeneca AB. This product will be manufactured at Lupin’s Pithampur facility in India.

Dapagliflozin and Saxagliptin Tablets (RLD Qtern) had estimated annual sales of USD 5 million in the U.S. (IQVIA MAT November 2023).