RARITAN, N.J., July 16 /PRNewswire/ -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. announced today that the U.S. Food and Drug Administration's (FDA) Anti-Infective Drugs Advisory Committee voted in favor of the efficacy and safety data for DORIBAX(TM) (doripenem for injection) for the treatment of hospital-acquired pneumonia, or nosocomial pneumonia (NP), and ventilator-associated pneumonia (VAP).
The committee voted that 500 mg of DORIBAX at both the one-hour and four-hour infusion regimens was safe (8-5) and effective (7-6). The committee did not agree on the appropriate non-inferiority margins for anti-infectives trials in nosocomial pneumonia.
The independent Advisory Committee provides recommendations based on its evaluation of the information presented. However, the final decision regarding approval of the drug is made by the FDA.
"We recognize that there is an important need for new antibiotics to treat these serious hospital infections," said Joanne Waldstreicher, M.D., Global Head, Drug Development, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. "We look forward to further discussions with the FDA as they complete their review of DORIBAX for the treatment of hospital-acquired and ventilator-associated pneumonia."
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 is approved in the U.S. 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-
|SOURCE Johnson & Johnson Pharmaceutical Research & Development,L.L.C.|
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