FDA: New Generic Valsartan

The US Food and Drug Administration has approved a new generic form of valsartan, an angiotensin II receptor blocker (ARB) for the treatment of hypertension and heart failure.

“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. “So, to address the public health consequences of these shortages, we’ve prioritized the review of generic applications for these valsartan products.”

Valsartan products and other ARBs that contained an impurity called N-nitrosodimethylamine (NDMA) were recalled last summer. NDMA can potentially cause cancer.

For this approval, the FDA monitored the drug’s manufacturing and testing processes to ensure there were no impurities.

—Amanda Balbi

Reference:

FDA approves a new generic valsartan [press release]. Silver Spring, MD: US Food and Drug Administration; March 12, 2019. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm633255.htm?utm_campaign=FDA%20approves%20a%20new%20generic%20valsartan&utm_medium=email&utm_source=Eloqua.