Health Canada gives Bayer's Xarelto first ever approval for VTE after surgery
Germany's Bayer Healthcare has received the first ever approval for its anticoagulant Xarelto (rivaroxaban) from Health Canada, the country's drug authority, for the prevention of venous thromboembolic events in patients who have undergone elective total hip or knee replacement surgery.
The once-daily, fixed-dose tablet administration of Xarelto, a direct Factor Xa inhibtor, was invented at Bayer's Wuppertal laboratories in Germany. The drug was jointly developed with US health care major Johnson & Johnson's Pharmaceutical R&D unit.
Xarelto has been recommended for approval in Europe by the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) and a New Drug Application has been submitted to the US Food and Drug Administration. If the drug is approved in the USA, it will be marketed there by Ortho-McNeil. Xarelto is also under review in 10 other countries.
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