- 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.