The US Food and Drug Administration has agreed to review Schering-Plough’s New Drug Application for its novel broad-spectrum quinolone antibiotic, garenoxacin.

The company is seeking approval to market the agent in the USA for the treatment of Gram-positive and Gram-negative bacterial infections, and plans to file a similar application with the European Medicines Agency later this year.

Garenoxacin was originally discovered by Japan’s Toyama Chemical, and Schering-Plough licensed worldwide rights - excluding Japan, South Korea and China – to the drug in June 2004, for $80 million plus royalties. At the time, Fred Hassan, S-P's Chairman and Chief Executive, said in a statement that the addition of garenoxacin would strengthen the company’s anti-infective portfolio, and that a filing with US regulators was expected in late 2005.