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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.
On February 13, 2006, Schering-Plough announced that the United States Food and Drug Administration has accepted the New Drug Application (NDA) for garenoxacin, and has been granted a 10-month review.
Schering-Plough later withdrew its application to the United States Food and Drug Administration, FDA, (August 20, 2006) for approval of the antibiotic Garenoxacin.
The European Medicines Agency (EMEA) had also been formally notified by Schering-Plough Europe (July 28 2007) of its decision to withdraw the application for a centralized marketing authorization for garenoxacin as well. Based on the CHMP review of the data regarding safety and efficacy (risk/benefit), the CHMP considered the application for garenoxacin to be unapprovable.
- "Drugs.com, Schering-Plough Reports Garenoxacin NDA Accepted for FDA Review". Retrieved 2008-03-25.
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