Bayer/J&J Will Resubmit Xarelto For Acute Indication In Second Half, Along With New Application For Chronic Use
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
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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