The European Medicines Agency (EMA) has also validated a Marketing Authorisation Application (MAA) for dapagliflozin.
The Prescription Drug User Fee Act (PDUFA) date the FDA is aiming for is reported as 28 October 2011.
On approval, dapagliflozin will be the first among novel agents for diabetes which inhibit sodium-glucose cotransporter-2 (SGLT2), a specific target located in the kidney.
The drug is designed to help control glycemia independently of insulin pathways, which would lead to the excretion of excess glucose and associated calories through urine.
The US and European submissions included Data from a global development program involving about 6,000 individuals in 40 clinical studies over two years was included in the US and European submissions.
The US application also has data assessing dapagliflozin’s cardiovascular safety in adults with type 2 diabetes.
The NDA and MAA submissions for dapagliflozin were filed in December 2010.
Bristol-Myers Squibb and AstraZeneca had entered into a collaborative agreement in January 2007 to develop and commercialize select investigational drugs for type 2 diabetes.
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