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Garenoxacin

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This is an old revision of this page, as edited by CheMoBot (talk | contribs) at 01:52, 10 August 2011 (Updating {{drugbox}} (no changed fields - added verified revid - updated 'ChemSpiderID_Ref', 'ChEMBL_Ref', 'ChEBI_Ref', 'StdInChI_Ref', 'StdInChIKey_Ref', 'ChEBI_Ref') per Chem/Drugbox validation). The present address (URL) is a permanent link to this revision, which may differ significantly from the current revision.

Revision as of 01:52, 10 August 2011 by CheMoBot (talk | contribs) (Updating {{drugbox}} (no changed fields - added verified revid - updated 'ChemSpiderID_Ref', 'ChEMBL_Ref', 'ChEBI_Ref', 'StdInChI_Ref', 'StdInChIKey_Ref', 'ChEBI_Ref') per Chem/Drugbox validation)(diff) ← Previous revision | Latest revision (diff) | Newer revision → (diff) Pharmaceutical compound
Garenoxacin
Clinical data
Routes of
administration		Oral
ATC code
Identifiers
IUPAC name
  • 1-cyclopropyl-8-(difluoromethoxy)-7--4-oxo-1,4-dihydroquinoline-3-carboxylic acid
CAS Number
PubChem CID
UNII
KEGG
CompTox Dashboard (EPA)
Chemical and physical data
FormulaC23H20F2N2O4
Molar mass426.412 g/mol g·mol
  (verify)

Garenoxacin (INN) is a quinolone antibiotic for the treatment of gram-positive and gram-negative bacterial infections.

It 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.

See also

References

  1. "Drugs.com, Schering-Plough Reports Garenoxacin NDA Accepted for FDA Review". Retrieved 2008-03-25.
  2. http://www.fiercebiotech.com/story/schering-plough-pulls-its-garenoxacin-app/2006-08-21
  3. http://www.medicalnewstoday.com/articles/78052.php
  4. http://www.emea.europa.eu/humandocs/PDFs/EPAR/garenoxacinmesylate/34117407en.pdf
  5. http://www.emea.europa.eu/humandocs/PDFs/EPAR/garenoxacinmesylate/H-747-WAR.pdf
  6. http://www.emea.europa.eu/humandocs/PDFs/EPAR/garenoxacinmesylate/H-747-WAR.pdf
Antibacterials that inhibit nucleic acid (J01E, J01M)
Antifolates
(inhibit bacterial
purine metabolism,
thereby inhibiting
DNA and RNA
synthesis)
DHFR inhibitor
Sulfonamides
(DHPS inhibitor)
Short-acting
Intermediate-acting
Long-acting
Other/ungrouped
Combinations
Other DHPS inhibitors
Quinolones
(inhibit bacterial
topoisomerase
and/or DNA gyrase,
thereby inhibiting
DNA replication)
1st generation
Fluoroquinolones
2nd generation
3rd generation
4th generation
Veterinary
Newer non-fluorinated
Related (DG)
Anaerobic DNA
inhibitors
Nitroimidazole derivatives
RNA synthesis
Rifamycins/
RNA polymerase
Lipiarmycins


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