US FDA extends review period for J&J's nosocomial infection drug

Johnson & Johnson Pharmaceutical Research and Development, L.L.C, said the US Food and Drug Administration (FDA) has extended the review timeline for the second New Drug Application for the antibiotic Doribax (doripenem for injection). The application, submitted in June 2007, seeks approval to market Doribax to treat nosocomial, or "hospital-acquired," pneumonia and ventilator-associated pneumonia, which occurs in patients who are on mechanical ventilation because they cannot breathe on their own.

The FDA extended the review period by three months to provide time for a full review of the application after receiving additional information it had requested from the company.

Doribax is already FDA-approved to treat complicated urinary tract and complicated intra-abdominal infections and is marketed by Ortho-McNeil , Division of Ortho-McNeil-Janssen Pharmaceutical Services, Inc., in the US. The use of Doribax to treat complicated urinary tract and complicated intra-abdominal infections and nosocomial pneumonia, including ventilator-associated pneumonia, currently is under regulatory review in Europe, Canada and in other countries. Doribax is licensed from Shionogi and Co., Ltd.

Doribax is indicated as a single agent for the treatment of: complicated intra-abdominal infections caused by susceptible strains of E. coli, K. pneumoniae, P. aeruginosa, B. caccae, B. fragilis, B. thetaiotaomicron, B. uniformis, B. vulgatus, S. intermedius, S. constellatus or P. micros, and for the treatment of complicated urinary tract infections, including pyelonephritis, caused by susceptible strains of E. coli, including cases with concurrent bacteremia, K pneumoniae, P. mirabilis, P. aeruginosa, or A baumannii.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Doribax and other antibacterial drugs, Doribax should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting and modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.