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Swiss approve ceftobiprole

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Swissmedic approves Basilea/Johnson & Johnson's ceftobiprole Nov. 13 to treat complicated skin and soft tissue infections, including diabetic foot infections. Already marketed in Canada as Zeftera, the novel broad-spectrum anti-MRSA cephalosporin antibiotic will be marketed in Switzerland as Zevtera. FDA recently accepted Basilea/J&J's response to an "approvable" letter for the compound in the U.S. for the same indication, giving the NDA a Class 2 designation, which means a six-month review (1Pharmaceutical Approvals Monthly May 2008, p. 6). On Nov. 18-20, FDA's Anti-Infective Drugs Advisory Committee is scheduled to discuss non-inferiority margins for CSSI studies and NDAs for possible competitors in the space, Theravance's telavancin and Arpida AG's iclaprim

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