Garenoxacin

Garenoxacin

File:Garenoxacin.svg
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 N
PubChem CID	124093
ChemSpider	110579 N
UNII	V72H9867WB
KEGG	D04031 Y
E number	{{#property:P628}}
ECHA InfoCard	{{#property:P2566}}
Chemical and physical data
Formula	C23H20F2N2O4
Molar mass	426.412 g/mol
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 N Key:NJDRXTDGYFKORP-LLVKDONJSA-N N
NY (what is this?)  (verify)

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Evidence Based Medicine
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Clinical Trials
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Definitions
Definitions of Garenoxacin
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International
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Experimental / Informatics
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

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.

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.