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Re: DewDiligence post# 165762

Tuesday, 04/08/2014 3:56:38 PM

Tuesday, April 08, 2014 3:56:38 PM

Post# of 257261
FDA approves Pradaxa for VTE treatment and secondary prevention:

http://finance.yahoo.com/news/fda-approves-pradaxa-dabigatran-etexilate-123500776.html

The label’s VTE treatment indication specifies that Pradaxa may be given after 5-10 days on an injected anticoagulant (usually Lovenox).

The European MAA for Pradaxa in the above indications was submitted on 6/24/13 (#msg-89322704) and is under review.

Competition: Xarelto is already approved for the VTE treatment/secondary prevention indication in the US (#msg-81103054) and EU (#msg-80711606); Eliquis has a US PDUFA date of 8/25/14 for this indication.

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