Lupin gets USFDA’s tentative approval for Dapagliflozin and Saxagliptin Tablets

05 Jan 2024 Evaluate

Lupin has received tentative approval from the United States Food and Drug Administration (USFDA) 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 $5 million in the U.S. (IQVIA MAT November 2023). 

Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.


Lupin Share Price

2160.20 12.65 (0.59%)
23-Dec-2024 16:59 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1814.50
Dr. Reddys Lab 1340.80
Cipla 1476.45
Lupin 2160.20
Zydus Lifesciences 972.95
View more..
© 2024 The Alchemists Ark Pvt. Ltd. All rights reserved. MoneyWorks4Me ® is a registered trademark of The Alchemists Ark Pvt. Ltd.