FDA Restricts Use Of Sanofi-Aventis Drug

Law360, New York (February 13, 2007, 12:00 AM EST) -- On the eve of a congressional hearing over drug safety, the U.S. Food and Drug Administration revealed label and usage changes for antibiotic Ketek.

The FDA said Monday that Sanofi-Aventis could no longer market Ketek for acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis. “The agency has determined that the balance of benefits and risks no longer support approval of the drug for these indications,” it said.

Ketek will remain on the market for community-acquired pneumonia. But the product labeling now carries a boxed...
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