FDA Panel Backs Safety Of AstraZeneca Diabetes Drug
Law360, Los Angeles (April 14, 2015, 10:26 PM EDT) -- A U.S. Food and Drug Administration committee has determined an AstraZeneca PLC diabetes drug is safe after conducting an investigation into a potential link to heart failure found in an earlier study, but it did recommend new labeling be added to the drug, the company announced Tuesday.
The agency had asked AstraZeneca to supply it with clinical trial data in order to examine a possible link between the drugmaker's saxagliptin and heart failure. Saxagliptin is marketed as Onglyza, which was approved by the FDA in July 2009, and Kombiglyze XR, which was approved in November 2010.
On Tuesday, AstraZeneca announced that...
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