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DewDiligence

08/28/13 11:20 AM

#165762 RE: DewDiligence #162994

FDA accepts Pradaxa sNDA for treatment of acute VTE:

http://finance.yahoo.com/news/fda-accepts-boehringer-ingelheims-supplemental-120000505.html

Pradaxa has a pending MAA for acute VTE treatment and secondary prevention in the EU (#msg-89322704).

Xarelto is already approved in the US and EU for the acute-PE subset of the above indication (#msg-81103054), while Eliquis appears to be a shoo-in for FDA approval for treatment of acute VTE and secondary prevention (#msg-89518539), although an sNDA submission has not yet been made.