FDA extends review for second NDA of Doribax

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. 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.

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, 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.