US-FDA grants tentative approval to Lupin 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 are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.Dapagliflozin and Saxagliptin Tablets (RLD Qtern) had estimated annual sales of USD 5 million in the U.S.
Optimize Your trial insights with Clival Database.
Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.
With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.
To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.
Elevate your trial success rate with the cutting-edge insights from Clival database.
Check it out today and make more informed sourcing decisions! Learn More!
