FDA extends review of J&J's Doribax

Johnson & Johnson Pharmaceutical Research and Development, a division of the US health care giant, says that the Food and Drug Administration has extended an ongoing review of the antibiotic Doribax (doripenem for injection) for nosocomial pneumonia indications by an additional three months.

Doribax, which is already cleared for the treatment of uncomplicated urinary tract and intra-abdominal infections, was filed for the pneumonia indication in June 2007 (Marketletters passim). The drug is currently under review by regulatory authorities in Europe, Canada and other countries around the world.