Garenoxacin

Garenoxacin

Systematic (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
Clinical data
Legal status	?
Routes	Oral
Identifiers
CAS number	194804-75-6 N
ATC code	J01MA19
PubChem	CID 124093
ChemSpider	110579 N
UNII	V72H9867WB Y
KEGG	D04031 Y
Chemical data
Formula	C23H20F2N2O4
Mol. mass	426.412 g/mol
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
N (what is this?)  (verify)

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