FDA issues complete response letter for Merck's diabetes drug labeling
The Food and Drug Administration (FDA) recently issued Merck a complete response letter for the company’s application for supplemental prescribing information on its labels for Januvia, Janumet and Janumet XR.
Merck’s applications to the FDA for the diabetes drugs were requesting to use data from its study, Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS), on its prescribing information relating to the medications, according to a company announcement. The TECOS trial involved patients with Type 2 diabetes and cardiovascular risk.
The company said it is currently reviewing the response and outlining its next steps with the FDA.
Merck received FDA approval for Januvia, which was the company’s first diabetes drug, in 2006 and launched the drug in 2007.
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