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The U.S. Food and Drug Administr ...

Posted Nov 10 2008 4:23pm

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.

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.

FDA Approves DORIBAX(TM) For The Treatment Of Complicated Intra-Abdominal And Complicated Urinary Tract Infections

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