Today, the FDA advised that it “recently became aware of a nitrosamine impurity, Nitroso‑STG‑19 (known as NTTP), in certain samples of sitagliptin, a medicine used to treat type 2 diabetes mellitus. To avoid a shortage and help ensure patients have access to an adequate supply of the medicine, the FDA will not object to the temporary […]
Yesterday, the Agency expressed confidence that manufacturers of varenicline tablets containing the N‑nitroso-varenicline impurity can meet the FDA’s original acceptable intake limit of 37 ng or less per day. Their statement read: “FDA is now confident in manufacturers’ ability to supply patients with varenicline containing the N-nitroso-varenicline impurity at or below the agency’s acceptable intake limit […]