FDA Allows for a New Generic Valsartan Approval comes in response to ARB shortage
The FDA approved a new generic for valsartan tablets after a priority review, according to an agency announcement. This valsartan product is made by Indian company.
Approval comes in the middle of a valsartan shortage stemming from multiple rounds of recalls of the angiotensin receptor blocker (ARB). Products were taken off the shelves starting last year in response to findings of potentially carcinogenic impurities, including N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA), in numerous lots of generics.
“So to address the public health consequences of these shortages, we’ve prioritized the review of generic applications for these valsartan products,” said FDA Commissioner Scott Gottlieb, MD, in a statement.
“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 statement continued. “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.”
“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.
In addition to valsartan, lots of losartan (Cozaar) and irbesartan (Avapro) are implicated in recalls. The FDA’s list of recalled ARBs continues to grow since the discovery of the NDMA and NDEA contamination last summer.
The list may get even longer as N-nitroso-N-methyl-4-aminobutyric acid (NMBA) was just recently found to be an impurity of interest.
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