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Dapagliflozin NDA resubmitted to FDA

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The FDA has received the new drug application resubmission for dapagliflozin, an investigational sodium-glucose cotransporter 2, according to a manufacturer press release.

Dapagliflozin (Bristol-Myers Squibb, AstraZeneca) was denied approval by the FDA in the United States in January 2012. Six months prior, the advisory committee recommended against the approval of the drug at a July 2011 meeting by a 9-6 vote due to concerns of potential breast or bladder cancer risks found in the 11 phase-3 clinical trials.

Now, the new drug application resubmission includes recent studies and additional long-term data compared with previously submitted studies, according to the press release.

The FDA assigned a new Prescription Drug User Fee Act goal date of January 11, 2014. It is currently approved for the treatment of type 2 diabetes in the European Union, Australia, Brazil, Mexico and New Zealand.

For more information:

BMS/AstraZeneca announcement. Accessed July 25, 2013.