AstraZeneca and Bristol-Myers Squibb Co. Oct. 26 announced that the Food and Drug Administration has extended the action date for the dapagliflozin new drug application by three months.
The new Prescription Drug User Fee Act (PDUFA) goal date is Jan. 28, 2012, the companies said. AstraZeneca and Bristol-Myers are seeking approval of the drug for the treatment of type 2 diabetes.
The companies said FDA requested additional data on the drug and they are submitting data from recently completed and ongoing phase III clinical trials. This data submission is a major amendment to the original NDA, which is why the ...
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