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FDA Delays Doribax, Rejecting Expert Advice Again

Posted on August 21, 2008

For the third time this month, the FDA has ignored a recommendation from outside experts to approve a marketing application for a drug. This time the setback was dealt to Johnson & Johnson s intravenous antibiotic drug Doribax. The agency says it needs more information before it can decide on the use of Doribax to treat the nasty kind of pneumonia patients pick up in hospitals. FDA approved Doribax last year for treatment of serious abdominal and urinary tract infections.Although not obligated to follow the recommendations of advisory committees, FDA historically has done so. But in early Au...

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pneumonia , urinary tract , urinary tract infections