Drug news

FDA issues Complete Response Letter for supplemental applications for Januvia (sitagliptin) and its combinations for treatment of type 2 diabetes. - Merck Inc.

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Last updated:27th Jun 2017

Published:9th Apr 2017

Source: Pharmawand

Merck 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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