Garenoxacin was discovered by Toyama Chemical Co., Ltd. of Tokyo, Japan, and is currently being marketed in Japan under the tradename Geninax. Schering-Plough holds worldwide rights for garenoxacin, except for Japan, South Korea, and China.[citation needed]
Schering-Plough later withdrew its application to the United States Food and Drug Administration, FDA, (August 20, 2006) for approval of the antibiotic Garenoxacin.[3]
The European Medicines Agency (EMA) had also been formally notified by Schering-Plough Europe (July 25, 2007) of its decision to withdraw the application for a centralized marketing authorization for garenoxacin as well.[4][5][6] Based on the CHMP review of the data regarding safety and efficacy (risk/benefit), the CHMP considered the application for garenoxacin to be unapprovable.[7]