FDA Seeks More Info On Bristol, AstraZeneca Diabetes Drug

Law360, New York (January 19, 2012, 8:42 PM EST) -- The U.S. Food and Drug Administration on Thursday handed back Bristol-Myers Squibb Co. and AstraZeneca PLC's new drug application for Type 2 diabetes treatment dapagliflozin, asking for additional clinical trial data to better assess the drug's risks.

The request for more data, issued in the FDA's complete response letter, could require another clinical trial in addition to those already completed by the companies, the companies said in a joint statement. Bristol-Myers Squibb and AstraZeneca will determine whether that is necessary as they further investigate the complete...
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