|CompTox Dashboard (EPA)|
|Chemical and physical data|
|Molar mass||426.412 g/mol g·mol−1|
|3D model (JSmol)|
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 had accepted the New Drug Application (NDA) for garenoxacin, and had been granted a 10-month review. As of 2015, however, it has not been approved in the USA.
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.