The FDA hasn't exactly said "no" to Johnson & Johnson's Doribax, but it has definitely said "not yet." J&J had asked the agency to expand the use of the IV antibiotic to hospital-acquired pneumonia; right now, it's only approved for serious abdominal and urinary tract infections. But the FDA said it needs more info before it makes a decision.
As you know, an advisory committee voted narrowly in favor of the new use for Doribax. But lately, the FDA has been going against its expert advice, as the Wall Street Journal Health Blog notes. It rejected Schering-Plough's sugammedex in spite of a unanimous approval rec. And it delayed a decision on J&J's psoriasis med, ustekinumab. That was another unanimous vote in favor.
In Doribax's case, FDA staff had expressed some doubts about the data J&J submitted in support of its pneumonia use, calling the info "flawed." The advisory committee, despite voting in favor of the new indication, questioned the design of the pneumonia trial. J&J hasn't said just what additional info the agency has asked for, and neither has the FDA; we'll have to wait and see whether the agency wants a whole new trial.
- read J&J's press release
- see the Health Blog's take
- check out the coverage in Forbes