Johnson & Johnson Pharmaceutical Research & Development, LLC (J&JPRD) announced that the US Food and Drug Administration (FDA) requires additional information before it will approve the company's New Drug Application (NDA) for Doribax (doripenem for injection) for the treatment of hospital-acquired pneumonia, also known as nosocomial pneumonia (NP), including ventilator-associated pneumonia (VAP).

In response to the J&JPRD application seeking approval for Doribax for the additional indication of the treatment of NP, including VAP, the FDA issued a complete response letter outlining the actions necessary to address outstanding issues.

J&JPRD is reviewing the agency's letter and will work to resolve any outstanding questions. The NDA for Doribax for the treatment of NP, including VAP, was submitted to the FDA in June 2007.

The NDA for Doribax for the treatment of NP, including VAP, was the subject of a July 16, 2008 US FDA Anti-Infective Drugs Advisory Committee.

Based on data presented from two large, nosocomial pneumonia trials, the committee voted that 500 mg of Doribax at both the one-hour and four-hour infusion regimens were safe (8-5) and effective (7-6) in the treatment of NP, including VAP. The committee did not agree that the non-inferiority margin for the Doribax NP trials was appropriately justified, nor did it agree on the appropriate margin for NP trials in general. J&JPRD is confident in the NP data submitted and will work with the FDA to address the issues raised in the complete response letter.

Doribax is an intravenous (IV) antibiotic for hospital use, and belongs to a class of antibacterial drugs called carbapenems. Carbapenems are important antibiotics to treat serious - and sometimes life-threatening - infections caused by a broad range of bacteria, which are characterized as gram-negative and gram-positive, based on a classification process that is used to identify the specific type of bacteria.

Doribax was approved in the US in October 2007 for the treatment of complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI), including pyelonephritis, due to susceptible bacteria, and is marketed by Ortho-McNeil, Division of Ortho-McNeil-Janssen Pharma, Doribax also is approved in Europe and Russia for cIAI, cUTI and NP, including VAP. Doripenem is licensed from Shionogi & Co, Ltd.