FDA Concerned With Side Effect of Oscient Drug

Law360, New York (September 11, 2006, 12:00 AM EDT) -- Armed with studies showing a high risk of skin rashes from Oscient Pharmaceuticals Corp.’s Factive antibiotic, regulators at the FDA have planned a meeting on the safety and efficacy of the sinusitis drug for Tuesday.

Oscient is seeking FDA approval for a five-day version of the drug meant to treat acute sinus infections. 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.

Sinusitis is an inflammation of the sinuses...
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