ARTICLE | Clinical News

Restanza cethromycin: SPA received

August 16, 2010 7:00 AM UTC

Advanced Life Sciences received an SPA from FDA for a planned Phase III trial to compare Restanza vs. Pfizer's Zithromax azithromycin. The double-blind trial, which is expected to start this year, will compare 300 mg oral Restanza given once daily vs. Zithromax after 7 days. The company received a complete response letter for Restanza to treat mild to moderate CAP last year after an FDA panel voted 11-3, with 1 abstention, that a pair of Phase III trials failed to establish Restanza's noninferiority to Abbott's Biaxin clarithromycin (see BioCentury, Aug. 3, 2009). ...