Quiz (low difficulty)—The EU rubber-stamped Pradaxa today for AF/stroke prevention. What did the EU do differently from the FDA with respect to Pradaxa in this indication?
Pradaxa was: approved in the EU for VTE prevention in 2008 (#msg-27956748), approved in the US for AF/stroke prevention in 2010 (#msg-55725156); and approved in the EU for AF/stroke prevention in 2011 (#msg-65889172). (B-I never submitted Pradaxa for approval for VTE prevention in the US.)