Lupin bags tentative USFDA nod for Dapagliflozin and Saxagliptin Tablets

Mumbai: Global pharma major Lupin Limited has 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, 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 are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin and Saxagliptin Tablets (RLD Qtern) had estimated annual sales of USD 5 million in the U.S. (IQVIA MAT November 2023).

Medical Dialogues team had earlier reported that Lupin had received tentative approval from the U.S. FDA for its Abbreviated New Drug Application (ANDA), Sitagliptin Tablets USP, 25 mg, 50 mg, and 100 mg to market a generic equivalent of Januvia Tablets, 25 mg, 50 mg, and 100 mg, of Merck Sharp and Dohme Corp.