FDA Wants More Info On J&J Drug For Pneumonia
Make a commentBy Ed Silverman // August 21st, 2008 // 8:44 am
The health care giant, however, doesn’t say exactly what info the agency is seeking about Doribax, which Johnson & Johnson hopes will be approved for treating hospital-acquired pneumonia. The drug is already approved to treat intra-abdominal and urinary tract infections.
Last month, an FDA advisory committee narrowly endorsed the intravaneous antibiotic for the pneumonia indication, despite serious concerns about how the drugmaker studied the medication (back story). As J&J noted, the panel failed, however, to agree on whether the goal set in clinical trials was justified.
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Doribax, Hospital-acquired Pneumonia, Johnson & Johnson