Schering-Plough Corporation Reports Garenoxacin NDA Accepted For FDA Review
KENILWORTH, N.J., Feb. 13 /PRNewswire-FirstCall/ -- 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.
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. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its more than 30,000 people around the world. The company is based in Kenilworth, N.J., USA, and its Web site is http://www.schering-plough.com.
Schering-Plough CorporationCONTACT: Media: Robert J. Consalvo, +1-908-298-7409, Investors: AlexKelly, +1-908-298-7436
Web site: http://www.schering-plough.com/
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