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DewDiligence

07/01/11 7:13 PM

#122735 RE: jq1234 #122725

Factoid—FDA has approved 20 NMEs during half of 2011 vs 21 NMEs in all of 2010. (Source: http://www.bloomberg.com/news/2011-07-01/novartis-wins-u-s-approval-on-medicine-to-treat-smoker-s-cough.html )
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jq1234

07/05/11 10:42 AM

#122853 RE: jq1234 #122725

FDA Advisory Panel on Xarelto for the prevention of
stroke and systemic embolism


On September 8, 2011, the committee will discuss new drug application (NDA)
202439, rivaroxaban tablets, submitted by Johnson & Johnson Pharmaceutical Research and
Development, L.L.C., on behalf of Ortho-McNeil-Janssen-Pharmaceuticals, for the prevention of
stroke and systemic embolism (blood clots other than in the head) in patients with nonvalvular
atrial fibrillation (abnormally rapid contractions of the atria, the upper chambers of the heart).

http://www.ofr.gov/OFRUpload/OFRData/2011-16862_PI.pdf