News
7 Apr 2017
Merck receives CRL from the FDA for TECOS study with sitagliptin
CRL relates to Merck's sNDA for Januvia, Janumet and Janumet XR.
Merck (MSD outside the US and Canada) has, announced that the FDA has issued a Complete Response Letter regarding Merck’s Supplemental New Drug Applications for Januvia (sitagliptin), Janumet (sitagliptin and metformin HCl) and Janumet XR (sitagliptin and metformin HCl extended-release).
With these applications, Merck is seeking to include data from TECOS (Trial Evaluating Cardiovascular Outcomes with Sitagliptin) in the prescribing information of sitagliptin-containing medicines. Merck is reviewing the letter and will discuss next steps with the FDA.
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