Talk:Garenoxacin

The current stub is in error regarding the current status of this drug.

The application for marketing authorization for Garenoxacin mesylate was submitted to the European Medicines Agency (EMEA) on May 5, 2006. Schering-Plough Europe withdrew its marketing authorization application for Garenoxacin mesylate on July 26, 2007. Believed to be the result of the letter of NON APPROVAL issued by the European Medicines Agency due to concerns regarding lack of efficacy as well as serious adverse reaction profile.

Based on the CHMP review of the safety and efficacy data the the European Medicines Agency decided that the application for Garenoxacin 400 mg tablet was NOT approvable for the treatment of community acquired pneumonia (CAP) in hospitalized patients, for acute exacerbation of chronic bronchitis (AECB) or for uncomplicated skin and soft tissue infections (USSTI). The application for Garenoxacin 600 mg tablet was NOT approvable for the treatment of complicated skin and soft tissue infections (CSSTI) or for intra-abdominal infections (IAI) and acute pelvic infections. The application for Garenoxacin 2mg/ml solution for infusion was NOT approvable for the treatment of CAP, CSSTI, IAI or acute pelvic infections. The major objection precluding a recommendation for marketing authorization pertains to deficiencies on the efficacy demonstration as well as adverse drug reactions.

The major safety issue for garenoxacin appears to be drug-related hypotension.

The European Medicines Agency (EMEA) has been formally notified by Schering-Plough Europe of its decision to withdraw the application for a centralized marketing authorization for the medicinal product Garenoxacin mesylate 400 mg and 600 mg film-coated tablets and 2 mg/ml solution for infusion.

A New Drug Application concerning Garenoxacin was also filed with the FDA, which Schering-Plough had also subsequently withdrawn. Toyama had expected the agency to approve the antibiotic, clearing the way for the Japanese drug developer to start earning revenue on U.S. sales. Schering-Plough dropped this application stating that it did not have a sub-licensee for the U.S. market. However we are of the opinion that for the same reasons cited by the European Medicines Agency (lack of efficacy and safety concerns) that the FDA would not have approved Garenoxacin and for this reason it was withdrawn, rather than the lack of a a sub-licensee cited by Schering-Plough.

For further information:

Withdrawal assessment report for Garenoxac in Mesylate (garenoxacin) http://www.emea.europa.eu/humandocs/PDFs/EPAR/garenoxacinmesylate/H-747-WAR.pdf

http://www.emea.europa.eu/humandocs/PDFs/EPAR/garenoxacinmesylate/34117407en.pdf 96.254.65.104 (talk) 23:42, 8 December 2008 (UTC)