approval of XARELTO
Xarelto was first approved for consumer use by Health Canada in September 2008 for the prevention of blood clots in those who had undergone hip or knee replacement operations. The European Medicines Agency approved it the same month for identical use.
FDA Approval in July 2011
In July 2011, the U.S. FDA approved Xarelto to prevent deep vein thrombosis (DVT) and pulmonary embolism in those who had undergone hip or knee surgery. That November, the agency approved it for stroke prevention in adults with atrial fibrillation.
In December 2011, Xarelto was approved by the European Medicines Agency to also prevent stroke and blood clots in adults with atrial fibrillation, to manage deep vein thrombosis (DVT), and to prevent recurring DVT and pulmonary embolism in those who had suffered a serious blood clot.
In November of 2012, the FDA granted approval to use Xarelto for the general treatment and prevention of DVT and pulmonary embolism. Finally, in May 2013, the EMA approved the drug to prevent blood clots in adults with verified acute coronary syndrome (ACS).