FDA To Review Possible Heart Risks With AstraZeneca PLC's Diabetes Drug

Published: Feb 12, 2014

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The U.S. Food and Drug Administration said it will review possible heart risks associated with AstraZeneca Plc's widely-used diabetes drug saxagliptin, marketed as Onglyza and Kombiglyze XR. The health regulator said it requested for data from clinical trials after the New England Journal of Medicine published data that showed a small rise in hospitalizations for heart failure among patients using saxagliptin. The data was published by NEJM in September and was based on a study supported by AstraZeneca and Bristol-Myers Squibb Co, with whom AstraZeneca co-developed the drug before buying all rights in a deal completed earlier this month.

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