News
9 Mar 2011
FDA Nods Dapagliflozin NDA
The FDA has accepted Bristol-Myers Squibb and AstraZeneca’s NDA for dapagliflozin, an investigational drug for the treatment of type 2 diabetes.
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 cardiovas
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