FDA Panel Shoots Down Oscient Request

Law360 (September 13, 2006, 12:00 AM EDT) -- A panel of the U.S. Food and Drug Administration said Tuesday that Oscient Pharmaceuticals Corp. had not proved its Factive drug is safe and effective enough to use for the treatment of acute bacterial sinusitis.

The leading ingredient in Factive, gemifloxacin, is already approved as a seven-day treatment for community-acquired pneumonia and a five-day treatment for certain cases of chronic bronchitis.

Studies have shown a high risk of skin rashes, though, when the drug is used for sinusitis, an inflammation of the sinuses caused by bacterial,...
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