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BMS/AstraZeneca re-file dapagliflozin at FDA

Read time: 1 mins
Last updated:27th Jul 2013
Published:27th Jul 2013
Source: Pharmawand

AstraZeneca and Bristol-Myers Squibb Company announced that the 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 percent.

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