FDA authorizes temporary distribution of contaminated losartan

In the midst of a series of recalls of sartan-contaminated drugs, the US Food and Drug Administration (FDA) announced on Wednesday that it would not oppose the temporary distribution of losartan-containing drugs. impurity N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) above the provisional acceptable intake limit of 0.96 parts per million (ppm) and below 9, 82 ppm until it can be eliminated.

The goal is to ensure continued access, said the FDA. The agency expects many companies to be able to manufacture losartan without nitrosamine impurities and replenish the US supply in about six months.

FDA scientists have badessed the risk of exposure to NMBA at concentrations of up to 9.82 ppm and found that there was "no significant difference" in the risk of cancer on 6 months compared to a lifetime exposure to NMBA at 0.96 ppm, said the agency in a statement. .

"The distribution of losartan containing up to 9.82 ppm NMBA will help maintain an adequate supply of losartan as companies get approval for manufacturing processes that produce losartan without nitrosamine for patients" , said the FDA.

The FDA said manufacturers should contact FDA's staff of drug shortages when their losartan tests indicate NMBA concentrations exceeding the temporary acceptable intake limit of 0.96 ppm. The FDA will determine on a case-by-case basis whether lots containing an NMBA greater than 0.96 ppm should be released for distribution.

NMBA is one of three nitrosamine impurities detected in angiotensin II receptor blockers, valsartan, losartan and irbesartan, as well as some combination medications containing these drugs since the ## 147 ## Summer 2018. The FDA maintains an up-to-date list of sartan products recalled on its website. .

Earlier this month, the FDA approved a new generic of valsartan (Diovan) manufactured by Alkem Laboratories.

"We know that ongoing reminders to prevent certain batches of valsartan containing unacceptable levels of impurities from reaching patients have resulted in a shortage of these important medications, so we have prioritized consideration of the consequences for patients. Public health of these shortages.General applications of these products based on valsartan, "said in a statement the FDA Commissioner, Scott Gottlieb, MD.

The FDA said it was working with companies and international regulators to ensure that products entering the US market do not contain nitrosamine impurities.