FDA delay for J&J's Doribax

US health care giant Johnson & Johnson says that the Food and Drug Administration requires additional information before it will approve the company's New Drug Application for Doribax (doripenem for injection) in the treatment of hospital-acquired pneumonia.

The FDA issued a Complete Response letter outlining the actions necessary to address outstanding issues. J&J says it is reviewing the agency's recommendations and will work to resolve any outstanding questions.

The NDA for Doribax in the treatment of nosocomial pneumonia, including ventilator-associated pneumonia, was submitted in June 2007. Despite the eventual request for further data, in July the FDA Anti-Infective Drugs Advisory Committee narrowly voted 8-5 in favor of the drug's safety and 7-6 of its effectiveness in the indication.