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Article: FDA Advisers Oppose Wider Label For Factive In Sinusitis.
- Article from:
- BIOWORLD Today
- Article date:
- November 3, 2009
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Washington Editor
GAITHERSBURG, Md. - The FDA's Anti-Infective Drugs Advisory Committee voted against expanding the label for Factive (gemifloxacin) to include acute bacterial sinusitis, absent an additional study to demonstrate its superiority.
The antibiotic's owner, Oscient Pharmaceuticals Corp., applied last year to market it as a five-day treatment for the condition, but regulators have questioned whether Factive's treatment benefits offset its risks given existing data on the drug. Executives from the Waltham, Mass.-based company declined to comment following the decision or detail what the next steps could entail.
But the FDA's position ...