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

RARITAN, N.J., Oct. 15 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved DORIBAX(TM) (doripenem for injection) as a new treatment for complicated intra-abdominal and complicated urinary tract infections, including pyelonephritis. DORIBAX has demonstrated activity against a wide range of Gram-positive(1) and Gram-negative(2) bacteria -- including Pseudomonas -- that cause these serious infections.

DORIBAX belongs to a class of antibacterial agents called carbapenems, which are important for treating serious infections caused by Gram-positive and Gram-negative bacteria.

The approval of DORIBAX is based on results of clinical trials in complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI). In two multi-center, prospective, randomized, double-blind studies, DORIBAX was found to be effective and well tolerated for the treatment of complicated intra-abdominal infections. In another multi-center, randomized, double-blind study and an additional single-arm, multi-center study, DORIBAX was found to be effective and well tolerated for the treatment of complicated urinary tract infections.

DORIBAX was effective against major organisms that cause cIAI and cUTI, including E. coli, B. fragilis, viridans group streptococci, Proteus species, K. pneumoniae and Pseudomonas aeruginosa.

Pseudomonas aeruginosa, a Gram-negative bacterium with increasing multi-drug resistance, is one of the leading causes of hospital-acquired (nosocomial) infections. In general, there are few antibiotics available or in development to treat these life-threatening Gram-negative infections.

"New agents are urgently needed to effectively treat Gram-negative and Gram-positive bacterial infections," said Joseph Solomkin, M.D., Professor of Surgery and Director of Research, University of Cincinnati College of Medicine. "The introduction of DORIBAX is important for the treatment of these serious infections as fewe
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SOURCE Ortho-McNeil, Inc.
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