Drug approvals remained flat in 2009: FDA
fda

The Food and Drug Administration cleared some new drugs and kept up the momentum with 2008, suggesting a much-touted push for drug safety has not slowed down approvals.

The new leaders of FDA stepped up early warnings about potential drug safety issues and citations to companies that violate regulations of safety.

The number of approvals to drugs went up to the 26 first-of-a-kind prescription medicines last year in comparison to 25 in 2008. These conclusions have been drawn from figures given by the Washington Analysis which is an investment group.

The drugs that were cleared in the year 2009 include Novartis’ kidney cancer drug Afinitor and Bausch and Lomb’s pink eye medicine Besivance.

The final figures of the year-end drug approvals will come in by this Friday to the FDA. The agency reported 25 new drugs that were approved.

FDA either updated or added 31 new “black box” warning labels to drugs already present in the market. That was much lesser than the previous 56 boxed warnings in the previous year which saw the agency issuing several broad warnings resulting in boxed labels for the entire groups of drugs.

The total figures in 2009 suggest a moderate approach to regulation by the FDA. This came along despite the concerns of the drug industry over the recently-appointed Obama administration officials causing fewer drug approvals.

President Barack Obama took measures last year to restore the credibility of the FDA by following a string of safety problems which involved everything ranging from peanut butter to blood thinners.

Commissioner Margaret Hamburg made an announcement in August about the sppeding up of the approval procedure and expanding the issuance of warning letters to companies which don’t follow FDA.

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