Garenoxacin
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Overview
Overview
Garenoxacin (INN) is a quinolone antibiotic for the treatment of Gram-positive and Gram-negative bacterial infections.
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.[1]
Schering-Plough later withdrew its application to the United States Food and Drug Administration, FDA, (August 20, 2006) for approval of the antibiotic Garenoxacin.[2]
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.[3][4][5] Based on the CHMP review of the data regarding safety and efficacy (risk/benefit), the CHMP considered the application for garenoxacin to be unapprovable.[6]
References
References
- ↑ “Drugs.com, Schering-Plough Reports Garenoxacin NDA Accepted for FDA Review”. Retrieved 2008-03-25.
- ↑ http://www.fiercebiotech.com/story/schering-plough-pulls-its-garenoxacin-app/2006-08-21
- ↑ http://www.medicalnewstoday.com/articles/78052.php
- ↑ http://www.emea.europa.eu/humandocs/PDFs/EPAR/garenoxacinmesylate/34117407en.pdf
- ↑ http://www.emea.europa.eu/humandocs/PDFs/EPAR/garenoxacinmesylate/H-747-WAR.pdf
- ↑ http://www.emea.europa.eu/humandocs/PDFs/EPAR/garenoxacinmesylate/H-747-WAR.pdf
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