FDA not objecting, temporarily, to losartan with NMBA

To ensure patient access to losartan, the US Food and Drug Administration has said it will not object to certain manufacturers temporarily distributing blood pressure drug 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.

The agency expects many companies will be able to manufacture losartan without nitrosamine impurities and replenish the US supply in approximately six months.

Agency scientists evaluated the risk of exposure to NMBA at levels up to 9.82 ppm and determined that it presents no meaningful difference in cancer risk over a six-month time period when compared to a lifetime of exposure to NMBA at 0.96 ppm. Distributing losartan containing NMBA up to 9.82 ppm, will help maintain adequate losartan supply while companies obtain approval for manufacturing processes that produce nitrosamine-free losartan for patients.