Garenoxacin

Garenoxacin (INN) is a quinolone antibiotic for the treatment of Gram-positive and Gram-negative bacterial infections.^[1]

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^N
PubChem CID	124093
ChemSpider	110579^N
UNII	V72H9867WB
KEGG	D04031^Y
ChEBI	CHEBI:131716^N
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^N Key:NJDRXTDGYFKORP-LLVKDONJSA-N^N
^NY (what is this?)  (verify)

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.^{[citation needed]}

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.^[2] As of 2015, however, it has not been approved in the US.^{[citation needed]}

Schering-Plough later withdrew its application to the United States Food and Drug Administration, FDA, (August 20, 2006) for approval of the antibiotic Garenoxacin.^[3]

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.^[4][5][6] Based on the CHMP review of the data regarding safety and efficacy (risk/benefit), the CHMP considered the application for garenoxacin to be unapprovable.^[7]

References

1. Takagi H, Tanaka K, Tsuda H, Kobayashi H (December 2008). "Clinical studies of garenoxacin". International Journal of Antimicrobial Agents. 32 (6): 468–74. doi:10.1016/j.ijantimicag.2008.06.032. PMID 18790608.
2. "Drugs.com, Schering-Plough Reports Garenoxacin NDA Accepted for FDA Review". Retrieved 2008-03-25.
3. "Schering-Plough pulls its garenoxacin app".
4. . MediLexicon International Ltd. 28 July 2007. Archived from the original on 2007-08-08. Retrieved 2009-05-30.
5. "Garenoxacin mesylate: Withdrawn application". European Medicines Agency (EMA). 17 September 2018. Retrieved 13 July 2020.
6. "Schering-Plough Europe withdraws its marketing authorisation applicationfor Garenoxacin mesylate". European Medicines Agency (EMA) (Press release). Retrieved 13 July 2020.
7. "Withdrawal Assessment report for Garenoxacin Mesylate (garenoxacin)" (PDF). European Medicines Agency. 18 October 2007.