FDA Issues Warning to Merck for Januvia
The Food and Drug Administration has issued a warning to Merck & Co. after the pharmaceutical giant failed to conduct a safety study for its diabetes drugJanuvia.
According to the Wall Street Journal, the FDA issued the warned to Merck on February 17, informing the pharma company that it was several months late in submitting data about a required safety study. The FDA had told Merck in 2009 that it needed to conduct a three month pancreatic safety study in a diabetic rodent model treated with the active ingredient in Januvia, sitagliptin.
In the warning letter, the agency stated that the violation was "concerning from a public health perspective” because the required study was "part of a written agreement between you and the FDA to conduct additional testing to further assess a signal of a serious risk of acute pancreatitis” associated with the use of Januvia.
There have been reports in the past of acute pancreatitis in patients who use Janunvia.
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