FDA approves generic valsartan heart drug among shortages

The drug's approval was made a priority to help relieve shortages caused by multiple recalls over contamination.

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By Jane Weaver

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 recent shortages caused by multiple recalls over 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.

The approval of the generic, called Diovan, was granted to Alkem Laboratories.

The FDA has a comprehensive list of recalled drugs.