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Johnson & Johnson files U.S. marketing application for expanded label of blood thinner Xarelto

Dec. 11, 2017 10:43 AM ETJohnson & Johnson (JNJ) StockBy: Douglas W. House, SA News Editor2 Comments
  • Johnson & Johnson (NYSE:JNJ -0.3%) unit Janssen Research & Development, LLC submits a supplemental New Drug Application (sNDA) to the FDA seeking approval to add a cardiovascular risk reduction claim and an acute limb ischemia risk reduction claim to the label of XARELTO (rivaroxaban).
  • The FDA first approved XARELTO in July 2011 for preventing deep vein thrombosis, followed by three additional approvals for new uses. The most recent approval was a reduction of venous thromboembolism risk claim in October.

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