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Treatment for Bacterial Infection

Schering-Plough Reports Garenoxacin NDA Accepted for FDA Review

KENILWORTH, N.J., February 13, 2006 -- Schering-Plough Corporation today reported that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for garenoxacin, a new type of broad-spectrum quinolone antibiotic for treating Gram-positive and Gram-negative bacterial infections, including those caused by anaerobic organisms and resistant bacterial strains. The NDA has been granted a 10-month review by FDA.

Schering-Plough is seeking U.S. marketing approval of garenoxacin for use in treating adult patients with certain bacterial infections. The company plans to file a similar new drug application for garenoxacin with the European Medicines Agency (EMEA) this year.

Garenoxacin is a novel des-F6-quinolone antibacterial agent discovered by Toyama Chemical Co., Ltd. of Tokyo, Japan. Schering-Plough licensed worldwide rights to develop, use and sell garenoxacin, excluding Japan, South Korea and China, in June 2004.

Posted: February 2006

Garenoxacin FDA Approval History

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