The US Food and Drug Administration (FDA) has accepted for review Schering-Plough's 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.
According to the company release, 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. Ltd. of Tokyo, Japan. Schering-Plough licensed worldwide rights to develop, use and sell garenoxacin, excluding Japan, South Korea and China, in June 2004.
Schering-Plough Corporation is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs.