Bayer Gets Chinese Approval for New Uses for Xarelto
Bayer's once-daily oral anticoagulant Xarelto (rivaroxaban) has been approved by the China Food and Drug Administration (CFDA) for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors. Additionally, the CFDA has approved Xarelto for the treatment of deep vein thrombosis (DVT) and for the reduction of the risk of recurrent DVT and pulmonary embolism (PE) following an acute DVT in adults. Since 2009, Xarelto has been available in China for the prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.
Rivaroxaban is an oral anticoagulant and is marketed under the brand name Xarelto and is approved for five indications across seven distinct areas of use, for protection against venous and arterial thromboembolic (VAT) conditions.
Rivaroxaban was discovered by Bayer HealthCare and is being jointly developed with Janssen Research & Development, LLC. Xarelto is marketed outside the US by Bayer HealthCare and in the US by Janssen Pharmaceuticals, Inc., a Johnson & Johnson Company.
Source: Bayer HealthCare