Schering-Plough's New Drug Application for antibiotic garenoxacin accepted for FDA review

By Elaine Rigoli

Tampa, Fla., Feb. 13 - Schering-Plough Corp. announced Monday that the Food and Drug Administration has accepted for review its New Drug Application for garenoxacin, a broad-spectrum quinolone antibiotic.

The review will last up to 10 months, according to a company release.

Schering-Plough is seeking U.S. marketing approval of garenoxacin for use in treating adult patients with certain bacterial infections. The company contends that garenoxacin can treat gram-positive and gram-negative bacterial infections, including those caused by anaerobic organisms and resistant bacterial strains.

The company plans to file a similar new drug application for garenoxacin with the European Medicines Agency this year.

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

Headquartered in Kenilworth, N.J., Schering-Plough is a science-based health care company.

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