> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA OKs Losartan with NMBA Below 9.82 PPM
- URL: https://www.fdaweb.com/fda-oks-losartan-with-nmba-below-9-82-ppm/
- Published: 2019-03-20T12:00:00.000Z
- Updated: 2026-09-15T01:14:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143663

FDA says that to assure patient access to the antihypertensive drug losartan, it will allow certain manufacturers to temporarily distribute losartan containing N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) above the interim acceptable intake limit of 0.96 parts per million (ppm) and below 9.82 ppm until the impurity can be eliminated. An agency [notice](https://www.fda.gov/Drugs/DrugSafety/ucm613916.htm?utm%5Fcampaign=Update%20on%20ARB%20recall%3A%20FDA%20not%20objecting%20to%20losartan%20with%20NMBA%20below%209.82%20ppm&utm%5Fmedium=email&utm%5Fsource=Eloqua) says FDA expects many companies will be able to manufacture losartan without nitrosamine impurities and replenish the U.S. supply in about six months.

The notice says agency scientists determined that the risk of NMBA exposure at levels up to 9.82 ppm presents no meaningful difference in cancer risk over a six-month time when compared to a lifetime of exposure to NMBA at 0.96 ppm.

“Manufacturers should contact FDA’s drug shortage staff when their testing of losartan shows levels of NMBA that exceed the interim acceptable intake limit of 0.96 ppm,” the notice says. “FDA will determine, on a case-by-case basis, whether lots containing NMBA greater than 0.96 ppm should be released for distribution.”