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# FDA Working on Januvia Shortage
- URL: https://www.fdaweb.com/fda-working-on-januvia-shortage/
- Published: 2022-08-10T12:00:00.000Z
- Updated: 2026-09-14T17:55:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152478

FDA says that to avoid a shortage, it will not object to the temporary distribution of sitagliptin (Merck’s Januvia) with the nitrosamine impurity Nitroso-STG-19 (NTTP) above the acceptable intake limit of 37 ng/day and up to 246.7 ng/day. An agency [notice](https://www.fda.gov/drugs/drug-safety-and-availability/fda-works-avoid-shortage-sitagliptin-following-detection-nitrosamine-impurity?ref=fdaweb.com) says FDA recently became aware of NTTP in certain samples of sitagliptin, which is used to treat Type 2 diabetes.

The notice says that the manufacturer of a marketed product containing sitagliptin should contact the CDER drug shortage staff when its testing shows NTTP levels over 37 ng/day. FDA says it will determine on a case-by-case basis whether those drugs should be released for distribution.