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Merck receives CRL from the FDA for TECOS study with sitagliptin

cphi-onlineApril 10, 2017

Tag: Merck , FDA

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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