Garenoxacin
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
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.
