Amid Drug Shortage, FDA Approves Generic Valsartan

The US Food and Drug Administration (FDA) today approved a new generic of Diovan (valsartan). The drug is an angiotensin II receptor blocker that treats high blood pressure as well as heart failure.

The approval comes after months of recalls for lots of valsartan that were found to contain traces of N- nitrosodimethylamine (NDMA), which has been called a probably human carcinogen.

The valsartan recalls began in July 2018, when 80 lots of Diovan were recalled due to the detection of trace amounts of impurities. There have also been recalls of other angiotensin II receptor blockers, including irbesartan and losartan.

“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,” said FDA Commissioner Scott Gottlieb, MD, in a press release.

Gottlieb, who recently announced his impending resignation from the FDA, added that the FDA has prioritized the review of generic applications for valsartan products due to the shortages caused by the recalls.

In addition to prioritizing this review, the FDA has been evaluating angiotensin II receptor blocker products for impurities, recalling any that are found to be contaminated, and investigating the manufacturing process that allows these impurities to form. New requirements are being implemented to prevent the development of these impurities, according to the FDA’s release.

“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,” said Gottlieb.

The FDA Commissioner added that the FDA will continue to work with manufacturers to approve drugs and help mitigate the ongoing shortage of angiotensin II receptor blockers.