No slowdown in FDA approvals in ’09

January 06, 2010|Associated Press

WASHINGTON - The number of new drugs cleared by the Food and Drug Administration last year kept pace with 2008’s tally, suggesting a push for greater drug safety has not slowed down approvals.

The FDA hasn’t tallied its year-end drug approvals, but as of Dec. 1 it reported 25 new drugs approved.

During 2009, the FDA added 31 new or updated “black box’’ warning labels to drugs already on the market. That was down from 56 such warnings in the previous year, when the agency issued several broad warnings that resulted in boxed labels for entire groups of drugs.

The 2009 totals suggest a moderate approach by the FDA, despite industry concerns that Obama administration policies instituted after a string of safety problems would result in fewer drug approvals.

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