FDA Fast-Tracks Approval of Generic Valsartan in Wake of Recalls

Patrice Wendling

March 12, 2019

Amid an ongoing series of tainted sartan drug recalls, the US Food and Drug Administration (FDA) has approved a new generic of valsartan (Diovan) to treat hypertension and heart failure. Approval was granted to Alkem Laboratories Ltd.

"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, MD, said in a news release. "So to address the public health consequences of these shortages, we've prioritized the review of generic applications for these valsartan products."

"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, who it was recently announced is stepping down from the agency.

The FDA has been wrestling with recalls of the angiotensin II receptor blockers (ARBs) valsartan, losartan, and irbesartan, as well as some combination drugs that contain these medications, after nitrosamine impurities were first detected last summer.

Initially that included the potentially cancer-causing impurity, N-nitrosodimethylamine (NDMA), and within months, N-Nitrosodiethylamine (NDEA). However, earlier this month the agency reported that a third nitrosamine impurity and potential human carcinogen, N-nitroso-N-methyl-4-aminobutyric acid (NMBA), had been detected in lots of losartan.

"For this approval, the FDA evaluated the company's manufacturing processes and also made sure they used appropriate testing methods to demonstrate that the valsartan product approved today does not contain NDMA or NDEA," the news release said. "The FDA's assessment of the manufacturing processes for the product determined that there is no known risk for the formation of other nitrosamine impurities."

Alkem Laboratories' manufacturing plant, located in Daman, India, was inspected by the FDA in January 2019, according to a company news release.

The FDA maintains an updated list of recalled sartan products on its website.

Follow Patrice Wendling on Twitter: @pwendl

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