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Amidst global recalls, regulator gives nod for new generic Valsartan

USFDA | Updated on March 15, 2019 Published on March 15, 2019

FDA Approved

This week, the US Food and Drug Administration approved a new generic version of Diovan (valsartan), an angiotensin II receptor blocker (ARB) that treats high blood pressure and heart failure. The reason this is important is because the US regulator prioritised the review of this drug application to help relieve the recent shortage of this critical medicine

The shortage was a result of multiple recalls of generic valsartan products from several manufacturers due to the finding that certain lots of valsartan and other ARB medicines contain nitrosamine impurities.

“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. “So, to address the public health consequences of these shortages, we’ve prioritised the review of generic applications for these valsartan products.” The new generic of Diovan was granted to Alkem Laboratories.

New testing methods

Since last summer, the FDA has investigated the presence of nitrosamine impurities in certain generic ARB products. FDA scientists have made strides in understanding how impurities may form during the manufacturing process and the agency is working with international drug regulatory agencies to make new testing methods available.

The FDA has also engaged drug manufacturers and helped facilitate manufacturing process changes to ensure ARBs are free of detectable levels of nitrosamine impurities.

The FDA continues to investigate ARB medicines that contain nitrosamine impurities and do not meet the agency’s quality standards, it said, adding that it will continue to update on recalled valsartan, losartan and irbesartan products as more information becomes available from ongoing testing.

Source: USFDA

Published on March 15, 2019
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