www.fdanews.com/articles/126356-j-amp-j-pulls-zeftera-from-canada-amid-trial-conduct-questions
J&J Pulls Zeftera From Canada Amid Trial Conduct Questions
April 20, 2010
Janssen-Ortho,
a Johnson & Johnson (J&J) company, is halting Canadian sales of Zeftera, its skin-infection treatment, after the FDA and the
EU expressed concerns about the sponsor’s conduct of clinical trials. The drugmaker planned to stop selling Zeftera (ceftobiprole) last week, Basilea
Pharmaceutica, which licensed the drug to J&J, said. Discussions with Health Canada stemmed from negative U.S. and EU regulatory recommendations about
ceftobiprole.
Clinical Trials Advisor
Clinical Trials Advisor