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Tougher FDA retains approval rate


US medicine regulators issued far fewer drugs warnings in 2009 compared to the previous year, and only approved one more treatment than in 2008, figures have shown.

According to investment research group Washington Analysis, the Food and Drug Administration (FDA) approved 26 first-of-a-kind prescription drugs in the past 12 months, including Bausch and Lomb’s conjunctivitis treatment Besivance, and kidney cancer drug Afinitor from Novartis.

Yet despite industry fears that Obama administration officials would be tougher on drug safety, the FDA only added 31 new or updated “black box” warning labels to existing drugs – much lower than the 56 issued in 2008.

That year, the agency issued several broad warnings which resulted in entire drug groups being “black boxed”, as well as approving 25 new prescriptive medicines.

An agency spokeswoman asked about the FDA’s total drug approvals on Tuesday said she could not confirm or comment on the numbers.

Copyright Press Association 2010


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