Lupin receives tentative approval from U.S. FDA for Dapagliflozin and Saxagliptin Tablets

Global pharma major Lupin Limited (Lupin) today 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).

Shares of Lupin Limited was last trading in BSE at Rs. 1397.90 as compared to the previous close of Rs. 1406.05. The total number of shares traded during the day was 87854 in over 3437 trades.

The stock hit an intraday high of Rs. 1422.10 and intraday low of 1394.20. The net turnover during the day was Rs. 123258779.00.

Source : Equity Bulls

Keywords

Lupin INE326A01037 TentativeApproval USFDA Dapagliflozin Saxagliptin Tablets