Nitrosamine Impurity Detected in Sitagliptin, Shipments in Japan to Continue with FDA-Set Limit: MSD/Ono

MSD said on September 1 that a nitrosamine impurity, Nitroso-STG-19 (NTTP), has been detected in its diabetes drugs Januvia (sitagliptin) and Sujanu (sitagliptin + ipragliflozin). A similar announcement was made by Ono Pharmaceutical the same day for Glactiv (sitagliptin). Both...read more