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.

 

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Whitepapers

Featured Webinars

>