FDA works to avoid shortage of sitagliptin following detection of nitrosamine impurity

To avoid a shortage and help ensure patients have access to an adequate supply of the medicine, FDA will not object to the temporary distribution of sitagliptin containing NTTP above the acceptable intake limit of 37 ng per day, and up to 246.7 ng per day.
Source: FDA Center for Drug Evaluation and Research - What's New - Category: Drugs & Pharmacology Authors: Source Type: news