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DewDiligence

07/11/13 9:02 PM

#163887 RE: DewDiligence #163813

Oops—that should read "FDA accepts Eliquis sNDA for primary VTE prevention..."
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DewDiligence

12/20/13 3:44 PM

#171648 RE: DewDiligence #163813

Eliquis PDUFA date is 8/25/14 for the (supplementary) indications of acute VTE treatment and secondary VTE prevention:

http://finance.yahoo.com/news/fda-accepts-review-eliquis-apixaban-220100204.html

Note: This sNDA is distinct from the pending sNDA in primary VTE prevention, which has a PDUFA date of 3/15/14 (#msg-89831288).
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DewDiligence

03/14/14 4:37 PM

#175502 RE: DewDiligence #163813

FDA approves Eliquis for VTE prevention following hip/knee replacement:

http://finance.yahoo.com/news/u-fda-approves-eliquis-apixaban-170000729.html

This is Eliquis’ second approved indication in the US; the first (and larger) indication is stroke prevention in AF.

Eliquis was approved in the EU for VTE prevention following hip/knee surgery way back in 2011 (#msg-61114160).