After multiple recalls, FDA approves new generic for valsartan

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The U.S. Food and Drug Administration has approved a new generic of the blood pressure medication valsartan to help alleviate a recent shortage due to multiple safety recalls.

Since last summer, the FDA has issued a number of recalls of certain generic valsartan medications, which is used to treat high blood pressure and heart failure, after detecting trace amounts of the cancer-causing chemical N-nitrosodimethylamine (NDMA). Follow-up testing revealed some batches of valsartan also contained N-Nitrosodiethylamine, or NDEA, and N-Nitroso-N-methyl-4-aminobutyric acid, or NMBA, which are also probable carcinogens.

Recalls have only involved generics of the drug, not the brand name Diovan. The new generic is being made by Alkem Laboratories Limited, based in Mumbai, India.

"We know that the ongoing recalls to prevent certain lots of valsartan that contain unacceptable limits of impurities from reaching patients has resulted in a shortage of these important medicines," FDA Commissioner Scott Gottlieb, M.D., said in a statement on Tuesday. "So to address the public health consequences of these shortages, we've prioritized the review of generic applications for these valsartan products."

Drug companies have recalled hundreds of lots of the blood pressure-lowering medications valsartan, losartan and irbesartan either alone or in combination with other drugs. The drugs are known as angiotensin II receptor blockers (ARB).

The first recall was in July 2018 when China's Zhejiang Huahai Pharmaceuticals recalled batches of valsartan for trace amounts of NDMA. Three drug companies in the U.S. distributed the tainted medicine: Major Pharmaceuticals; Teva Pharmaceutical Industries; and Solco Healthcare. Other recalls from Mylan Pharmaceuticals, Aurobindo Pharma USA, Inc., and Torrent Pharmaceuticals Limited followed.

The FDA said investigators evaluated Alkem's manufacturing processes and tested their drugs to make sure they do not contain any amounts of the cancer-causing chemicals found in competitors' blood pressure medications. FDA scientists will continue to evaluate all ARBs currently on the market to look for any impurities.

"We hope that today's approval of this new generic will help reduce the valsartan shortage, and we remain committed to implementing measures to prevent the formation of these impurities during drug manufacturing processes for existing and future products," Gottlieb said.

The FDA advises people who are taking valsartan from a recalled batch to continue taking their current medicine until their doctor or pharmacist provides a replacement or a different treatment option.