Garenoxacin
Encyclopedia
Garenoxacin is a quinolone antibiotic for the treatment of gram-positive and gram-negative bacterial infections.
It 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.
It was discovered by Toyama Chemical Co., Ltd. of Tokyo, Japan, and is currently being marketed in Japan
Japan
Japan is an island nation in East Asia. Located in the Pacific Ocean, it lies to the east of the Sea of Japan, China, North Korea, South Korea and Russia, stretching from the Sea of Okhotsk in the north to the East China Sea and Taiwan in the south...
under the tradename Geninax. Schering-Plough
Schering-Plough
Schering-Plough Corporation was a United States-based pharmaceutical company. It was founded in 1851 by Ernst Christian Friedrich Schering as Schering AG in Germany. In 1971, the Schering Corporation merged with Plough to form Schering-Plough. On November 4, 2009 Merck & Co...
holds worldwide rights for garenoxacin, except for Japan, South Korea
South Korea
The Republic of Korea , , is a sovereign state in East Asia, located on the southern portion of the Korean Peninsula. It is neighbored by the People's Republic of China to the west, Japan to the east, North Korea to the north, and the East China Sea and Republic of China to the south...
, and China
China
Chinese civilization may refer to:* China for more general discussion of the country.* Chinese culture* Greater China, the transnational community of ethnic Chinese.* History of China* Sinosphere, the area historically affected by Chinese culture...
.
On February 13, 2006, Schering-Plough announced that the United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
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.