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FDA Acknowledges Receipt of Resubmission of New Drug Application from AstraZeneca PLC and Bristol-Myers Squibb Co


Friday, 26 Jul 2013 02:09am EDT 

AstraZeneca PLC and Bristol-Myers Squibb Co announced that the United States Food and Drug Administration (FDA) has acknowledged receipt of the New Drug Application (NDA) resubmission for investigational drug dapagliflozin for the treatment of adults with type 2 diabetes. The FDA assigned a new Prescription Drug User Fee Act goal date of January 11, 2014. The dapagliflozin Phase II/III clinical development program included more than 12,000 adult patients with diabetes (more than 8,000 patients received dapagliflozin) in 26 clinical trials. In response to the FDA’s January 2012 complete response letter requesting additional data to allow a better assessment of the benefit-risk profile of dapagliflozin, the NDA resubmission includes several new studies and additional long-term data (up to four years’ duration) from previously submitted studies, resulting in an overall increase in patient -years exposure to dapagliflozin of more than 50%. 

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