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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 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. Schering-Plough later withdrew its application to the United States Food and Drug Administration, FDA, (August 20, 2006) for approval of the antibiotic Garenoxacin.〔http://www.fiercebiotech.com/story/schering-plough-pulls-its-garenoxacin-app/2006-08-21〕 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.〔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〕 Based on the CHMP review of the data regarding safety and efficacy (risk/benefit), the CHMP considered the application for garenoxacin to be unapprovable.〔 http://www.emea.europa.eu/humandocs/PDFs/EPAR/garenoxacinmesylate/H-747-WAR.pdf〕 ==References== 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「Garenoxacin」の詳細全文を読む スポンサード リンク
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