ARTICLE | Clinical News

Restanza cethromycin regulatory update

March 15, 2010 7:00 AM UTC

Advanced Life Sciences said it plans to finalize an SPA with FDA by the end of 3Q10 for a pair of Phase III superiority trials that will compare Restanza cethromycin vs. a marketed macrolide antibiotic for community acquired pneumonia (CAP) and biodefense indications. The company said its development plan is based on discussions with FDA's Anti-Infectives Division as well as the outcome of a meeting last December of the agency's Anti-Infective Drugs Advisory Committee that discussed trial designs for CAP. Advanced Life Sciences received a complete response letter for Restanza to treat mild to moderate CAP last year. The NDA was based on Phase III data demonstrating Restanza is noninferior to Abbott's Biaxin clarithromycin (see BioCentury, Aug. 3, 2009). ...