cphi-onlineApril 10, 2017
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.
Contact Us
Tel: (+86) 400 610 1188
WhatsApp/Telegram/Wechat: +86 13621645194
Follow Us: