Notice: Function _load_textdomain_just_in_time was called incorrectly. Translation loading for the wordpress-seo domain was triggered too early. This is usually an indicator for some code in the plugin or theme running too early. Translations should be loaded at the init action or later. Please see Debugging in WordPress for more information. (This message was added in version 6.7.0.) in /var/www/html/wp-includes/functions.php on line 6260 FDA Accepts Dapagliflozin NDA | Contract Pharma

What are you searching for?

Sign in
Breaking News, Trials & Filings

FDA Accepts Dapagliflozin NDA

Bristol-Myers Squibb and AstraZeneca’s NDA for dapagliflozin, an investigational drug for the treatment of type 2 diabetes, has been accepted by the FDA.

Author Image

By: Tim Wright

Editor-in-Chief, Contract Pharma

Bristol-Myers Squibb and AstraZeneca’s NDA for dapagliflozin, an investigational drug for the treatment of type 2 diabetes, has been accepted by the FDA. Also, a MAA for dapagliflozin has been validated by the EMA. Both submissions were filed in December 2010. The Prescription Drug User Fee Act (PDUFA) goal date for the FDA is October 28, 2011.

The submissions included two years of data from a global development program involving approximately 6,000 individuals in 40 clinical studies. The U.S. application also includes data assessing the cardiovascular safety of dapagliflozin in adults with type 2 diabetes.

If approved, Dapagliflozin would be the first in a new class of drugs that inhibits sodium-glucose cotransporter-2 (SGLT2), which is designed to help control glycemia independently of insulin pathways, leading to the excretion of excess glucose.
@font-face { font-family: “Cambria”; }p.MsoNormal, li.MsoNormal, div.MsoNormal { margin: 0in 0in 0.0001pt; font-size: 12pt; font-family: “Times New Roman”; }div.Section1 { page: Section1; }

Add us as a preferred source on Google

Get the latest Contract Pharma news, insights and analysis in your Google Search and AI experiences.

Add Contract Pharma as a preferred source on Google (opens in a new tab)

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters