FDA approves new generic valsartan to alleviate shortage

The FDA approved a new generic of valsartan Feb. 12 to help relieve the shortage of the critical blood pressure drug that resulted from a string of recent recalls.

Since last summer, several drugmakers have recalled their generic valsartan medications after the FDA discovered that some lots of the drug contained a probable human carcinogen.

After the initial recall, the FDA found that other types of generic blood pressure medications containing losartan or irbesartan were tainted with the probable cancer-causing impurities as well.

"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.

The FDA prioritized review of the new generic, Diovan, to address the shortage.

Read the full news release here.

 

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