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Xarelto “Complete Response” No Surprise, But Does FDA Want Data, A REMS Or Both?

This article was originally published in The Pink Sheet Daily

Executive Summary

Approval could be pushed out to 2010 if the agency wants to review data from the ATLAS study, which completed too late to get into the NDA package.

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Bayer/J&J Will Resubmit Xarelto For Acute Indication In Second Half, Along With New Application For Chronic Use

Bayer/J&J plan to file the first chronic indication for their anticoagulant Xarelto, as well as respond to FDA on the "complete response" letter for their application for acute use in hip and knee replacement surgery, in the second half of 2010, Bayer CEO Werner Wenning announced Feb. 26 during the firm's 2009 year-end report

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