Garenoxacin

Last updated
Garenoxacin
Garenoxacin.svg
Clinical data
Routes of
administration 		Oral
ATC code
Identifiers
  • 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
PubChem CID
ChemSpider
UNII
KEGG
ChEBI
CompTox Dashboard (EPA)
Chemical and physical data
Formula C23H20F2N2O4
Molar mass 426.420 g·mol−1
3D model (JSmol)
  • FC(F)Oc1c(ccc2c1N(/C=C(\C2=O)C(=O)O)C3CC3)c4ccc5c(c4)CN[C@@H]5C
  • 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 X mark.svgN
  • Key:NJDRXTDGYFKORP-LLVKDONJSA-N X mark.svgN
 X mark.svgNYes check.svgY  (what is this?)    (verify)

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

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". 20 August 2006.
  4. ↑ "Schering-Plough Europe Withdraws Its Marketing Authorisation Application For Garenoxacin Mesylate". 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.
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