Schering-Plough Europe Withdraws Garenoxacin Mesylate Application

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

According to the EMEA, garenoxacin mesylate was expected to be used for the treatment of the following infections in adults when due to garenoxacin-susceptible pathogens: acute bacterial exacerbation of chronic bronchitis; acute bacterial sinusitis; community-acquired pneumonia; uncomplicated skin and skin structure infections; complicated skin and skin structure infections, including diabetic foot infections; and complicated intra-abdominal infections, including postsurgical and acute pelvic infections.

The company submitted the application for marketing authorization May 5, 2006, and was undergoing review by the Committee for Medicinal Products for Human Use (CHMP), the agency said.

The company stated that the withdrawal of garenoxacin mesylate was based on the CHMP’s request for additional information, to which the company was unable to respond within the permitted timeframe, the agency added.