Johnson & Johnson Pharmaceutical Research & Development announced that 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.
This article was published in Drug Discovery & Development magazine: Vol. 11, No. 4, April, 2008, pp. 30.
Filed Under: Drug Discovery