FDA wants more information on Doribax

Johnson & Johnson is having a hard time making its case to the FDA for using Doribax as a therapy for hospital-acquired pneumonia. The agency says it wants to see more information on the drug before giving the drug its stamp of approval for that indication. Johnson & Johnson filed for the approval more than a year ago.

An expert committee had voted to endorse the drug, but differed on whether the goal set in the clinical trial was justified. The company declined to detail exactly what the FDA is looking for, but says it will work with regulators to gain the approval.

--read the AP report

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