Schering-Plough antibiotic accepted for review by FDA

Garenoxacin is 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.

Schering-Plough is seeking US 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 of Tokyo, Japan. Schering-Plough licensed worldwide rights to develop, use and sell garenoxacin in all territories excluding Japan, South Korea and China, in June 2004.