Posted by Michael Wonder on 07 Apr 2017
Merck receives complete response letter from the U.S. FDA for TECOS study with sitagliptin
7 April 2017 - Merck today announced that the U.S. FDA has issued a complete response letter regarding Merck’s supplemental new drug applications for Januvia (sitagliptin), Janumet (sitagliptin and metformin hydrochloride) and Janumet XR (sitagliptin and metformin hydrochloride 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.
