The drug's approval was made a priority to help relieve shortages caused by multiple recalls over contamination.
Get breaking news alerts and special reports. The news and stories that matter, delivered weekday mornings.The Food and Drug Administration approved a new generic of the heart medicine valsartan on Tuesday. The FDA said it had made review of the drug a priority to help relieve recentover concerns that the medication may be contaminated with a cancer-causing chemical.
A number of generic valsartan products sold in the U.S., used to treat high-blood pressure, have been found to be tainted with trace amounts of the chemical NDEA or NDMA, N-nitrosodimethylamine, which the FDA has classified as a “probable human carcinogen.” While the risk to individual patients from the tainted batches is low, the newly approved valsartan product does not contain NDMA or NDEA, the FDA said in a statement.
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