Garenoxacin

Garenoxacin
Clinical data
Routes of; administration	Oral
ATC code	J01MA19 (WHO) ;
Identifiers
	IUPAC name 1-Cyclopropyl-8-(difluoromethoxy)-7-[(1R)-1-methyl-2,3-dihydro-1H-isoindol-5-yl]-4-oxo-1,4-dihydroquinoline-3-carboxylic acid;
CAS Number	194804-75-6 ;
PubChem CID	124093;
ChemSpider	110579 ;
UNII	V72H9867WB;
KEGG	D04031 ;
ChEBI	CHEBI:131716 ;
CompTox Dashboard (EPA)	DTXSID30173135 ;
Chemical and physical data
Formula	C23H20F2N2O4
Molar mass	426.420 g·mol−1
3D model (JSmol)	Interactive image;
	SMILES FC(F)Oc1c(ccc2c1N(/C=C(\C2=O)C(=O)O)C3CC3)c4ccc5c(c4)CN[C@@H]5C;
	InChI InChI=1S/C23H20F2N2O4/c1-11-15-5-2-12(8-13(15)9-26-11)16-6-7-17-19(21(16)31-23(24)25)27(14-3-4-14)10-18(20(17)28)22(29)30/h2,5-8,10-11,14,23,26H,3-4,9H2,1H3,(H,29,30)/t11-/m1/s1 ; Key:NJDRXTDGYFKORP-LLVKDONJSA-N ;
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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.[1] As of 2015, however, it has not been approved in the US.

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 (EMA) had also been formally notified by Schering-Plough Europe (July 25, 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

"Drugs.com, Schering-Plough Reports Garenoxacin NDA Accepted for FDA Review". Retrieved 2008-03-25.
"Schering-Plough pulls its garenoxacin app".
http://www.medicalnewstoday.com/articles/78052.php
"Garenoxacin mesylate: Withdrawn application". European Medicines Agency (EMA). Retrieved 13 July 2020.
"Schering-Plough Europe withdraws its marketing authorisation applicationfor Garenoxacin mesylate". European Medicines Agency (EMA) (Press release). Retrieved 13 July 2020.
http://www.emea.europa.eu/humandocs/PDFs/EPAR/garenoxacinmesylate/H-747-WAR.pdf%5B%5D

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[1] "Drugs.com, Schering-Plough Reports Garenoxacin NDA Accepted for FDA Review". Retrieved 2008-03-25.

[2] "Schering-Plough pulls its garenoxacin app".

[3] ttp://www.medicalnewstoday.com/articles/78052.php

[4] "Garenoxacin mesylate: Withdrawn application". European Medicines Agency (EMA). Retrieved 13 July 2020.

[5] "Schering-Plough Europe withdraws its marketing authorisation applicationfor Garenoxacin mesylate". European Medicines Agency (EMA) (Press release). Retrieved 13 July 2020.

[6] ttp://www.emea.europa.eu/humandocs/PDFs/EPAR/garenoxacinmesylate/H-747-WAR.pdf%5B%5D