FDA temporarily raising tolerance on impurities due to market shortage

FDA temporarily retreating on impurities for market shortage

FDA has issued setting temporary rules on a probable cancer-causing impurity formerly regulated. To avoid market shortage of Losartan, drugmakers will be able to make losartan with an impurity percentage above its prescribed level for six months while the supply of clean drugs is ramped up.

A calculated risk, to preserve blood pressure drugs availability for patients.

Scientists assured that the health risk from the impurity is low enough to sustain an exposure for another six months without notable differences, as the FDA evaluated that the chance of patients having heart trouble because they can’t get any losartan was a bigger risk than temporary raising up the acceptance levels.

The measure is limited to nitrosamine in Losartan formulations only.

The action, announced on February 28th , applies only to losartan and only to the impurity N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), one of three impurities that the FDA has determined can occur during the manufacturing of the blood pressure drugs losartan, valsartan and irbesartan.
“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,” the FDA said.

Every exceeding in the new tolerance will still be monitored by FDA

The FDA still obbligated losartan manufacturers that find their supplies to fall between interim acceptable intake limit to notify the agency, that will determine on a case-by-case basis whether to allow the drugs on the market.

Shortages in Losartan formulations started last summer, Diovan generic formulations approved to back-up market demand.

The initial discovery of tainted sartan products came last summer, after a U.S. drug manufacturer found NDMA at a high level in the API for valsartan that it got from a Chinese supplier.
The surprise findings led to global recalls of hundreds of lots of the mentioned formulations and an intensive FDA investigation into how it could have happened and the potential dangers to patients’ health. In the meantime, shortages have developed. The FDA this month approved a new impurity-free generic, Diovan, to help relieve supply shortages flowing from massive recalls.