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FDA Approves DORIBAX(TM) for the Treatment of Complicated Intra-Abdominal and Complicated Urinary Tract Infections
Date:10/15/2007

r antibiotics appear to effectively eradicate many troublesome bacteria, such as Pseudomonas."

Approximately two million intra-abdominal procedures are performed in the U.S. each year. Complicated intra-abdominal infections are infections that extend beyond the hollow cavity of the abdomen into the peritoneal space and are a common cause of hospitalization following these procedures.

Urinary tract infections (UTIs) account for at least 40% of all hospital infections. Although many cases of UTI are uncomplicated, a significant proportion of UTIs are classified as complicated because of anatomical abnormalities in the urinary tract, which make clearance of bacteria more difficult, or cause kidney infection (pyelonephritis). Complicated UTIs can be caused by a broad range of bacteria, many of which are resistant to multiple antibiotics.

DORIBAX will be marketed to U.S. hospitals and other healthcare institutions by Ortho-McNeil, Inc. through its Institutional Franchise. The use of doripenem in the treatment of hospital-acquired (nosocomial) pneumonia, including ventilator-associated pneumonia, is under regulatory review in the U.S., and the use of doripenem for complicated intra-abdominal infections, complicated urinary tract infections and nosocomial pneumonia, including ventilator-associated pneumonia, is under regulatory review in Europe. Doripenem is licensed from Shionogi & Co., Ltd., which launched the product in Japan in September 2005 under the name, FINIBAX.

INDICATIONS

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. pn
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SOURCE Ortho-McNeil, Inc.
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