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Post# of 257566
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DewDiligence

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DewDiligence

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Re: genisi post# 78581

Wednesday, 01/05/2011 7:27:02 AM

Wednesday, January 05, 2011 7:27:02 AM

Post# of 257566
Bayer/JNJ announce multiple Xarelto regulatory submissions:

http://www.bayer.com/en/news-detail.aspx?newsid=14326

• Initial EU submission for stroke prevention in AF, based on ROCKET-AF study (#msg-56712414,

• Initial EU submission for treatment of acute DVT, based on EINSTEIN-DVT study (#msg-53887547).

• FDA re-submission for VTE prevention following hip/knee surgery in response to FDA CRL issued in May 2009 (#msg-38200098).

Note: Xarelto was approved in the EU in 2008 for VTE prevention following hip/knee surgery (#msg-30972846), the indication for which JNJ is seeking FDA approval.

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