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Onglyza Data From Sentinel Pilot Can Be Validated By Phase IV Trial, FDA Says

Executive Summary

Bristol-Myers Squibb/AstraZeneca’s type 2 diabetes treatment Onglyza (saxagliptin) has been chosen as the focus of the first drug evaluation in the mini-Sentinel active safety surveillance project in part because observational findings on the drug can be compared to a large Phase IV clinical trial now under way.

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