Generic Valsartan Approval: FDA's New Generic Drug Against FDA High Blood Pressure After Several Recalls

The US Food and Drug Administration has approved a new generic drug called valsartan, a drug for the treatment of high blood pressure, to address the recent drug shortage several security reminders.

Since last summer, the FDA has released a number of reminders some generic drugs valsartan, which is used to treat high blood pressure and cardiac arrest, after detecting traces of the carcinogenic chemical N-nitrosodimethylamine (NDMA). Follow-up tests revealed that some batches of valsartan also contained N-nitrosodiethylamine, or NDEA, and N-nitroso-N-methyl-4-aminobutyric acid, or NMBA, which are also likely carcinogens. .

The recalls are for generic drugs only, not the brand name Diovan. The new generic is manufactured by Alkem Laboratories Limited, based in Mumbai, India.

"We know that ongoing recalls to prevent certain lots of valsartan containing unacceptable levels of impurities reaching patients have resulted in a shortage of these important drugs," said FDA Commissioner Scott Gottlieb on Tuesday. MD "So, to deal with the consequences of these shortages on public health, we have prioritized the review of generic applications of these valsartan-based products."

Pharmaceutical companies have recalled hundreds of antihypertensive drugs such as valsartan, losartan and irbesartan, alone or in combination with other drugs. The drugs are known as angiotensin II receptor blockers (ARAs).

The first recall took place in July 2018 when Chinese company Zhejiang Huahai Pharmaceuticals recalled batches of valsartan containing traces of NDMA. In the United States, three pharmaceutical companies distributed the contaminated drug: Major Pharmaceuticals; Teva Pharmaceutical Industries; and Solco Healthcare. Other reminders of Mylan Pharmaceuticals, Aurobindo Pharma USA, Inc.and Torrent Pharmaceuticals Limited followed.

The FDA said the investigators had assessed Alkem's manufacturing processes and had tested their drugs to make sure they contained no amount of cancer-causing chemicals found in blood pressure medications of their competitors. FDA scientists will continue to evaluate all current ARAs on the market for impurities.

"We hope that today's approval of this new generic drug will help reduce the shortage of valsartan, and we remain committed to taking steps to prevent the formation of these impurities in the future." process of making drugs for existing and future products, "said Gottlieb.

Consumers can see the full list of medications recalled on the FDA website.

The FDA advises people taking valsartan from a recalled lot to continue taking their current medication until their doctor or pharmacist offers them alternative treatment or a different treatment.