Health Canada Takes Alternative View To The US FDA

July 2008 | Product Launch

The first approval of Swiss firm Basilea Pharmaceutica's anti-infective, Zeftera (ceftobiprole), has once again highlighted the differences in regulatory agencies. After reviewing the drug's dossier for nearly 12 months, Health Canada was satisfied with the cephalosporin's safety, efficacy and quality of manufacture, and accordingly gave the green light for commercialisation. This was despite the US FDA rejecting the Zeftera in March 2008 and asking for a further assessment of drug's clinical data.

If you would like to subscribe to Americas Pharma & Healthcare Insight and gain instant access to this article, please click here to subscribe.

If you would like to take a trial to Americas Pharma & Healthcare Insight please click on the trial link below.