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Janssen announced that the FDA has issued a second complete response letter regarding a supplemental New Drug Application for Xarelto (rivaroxaban) for the reduction of the risk of cardiovascular events in patients with acute coronary syndrome.

Janssen announced that the FDA has approved Xarelto (rivaroxaban), an oral anticoagulant, for the treatment of deep vein thrombosis (DVT) and/or pulmonary embolism (PE), and to reduce the risk of recurrence of DVT and PE following initial treatment.

Risk factors, prevention strategies, signs & symptoms, and general treatment options for deep vein thrombosis (DVT) and pulmonary embolism (PE).

Janssen Research & Development announced today that it has submitted the Complete Response to the FDA for the use of Xarelto (rivaroxaban) to reduce the risk of secondary cardiovascular events in patients with acute coronary syndrome (ACS).

Janssen Research & Development announced that the FDA has assigned a priority review designation to the supplemental New Drug Applications (sNDAs) for Xarelto (rivaroxaban) seeking new indications to treat patients with deep vein thrombosis (DVT), pulmonary embolism (PE), and to prevent recurrent DVT and PE.

Janssen Research & Development announced that it has submitted a supplemental New Drug Application (sNDA) to the FDA seeking approval for the use of Xarelto (rivaroxaban) to reduce the risk of stent thrombosis in patients with Acute Coronary Syndrome (ACS).

Janssen Research & Development announced that it has submitted supplemental New Drug Applications (sNDAs) to the FDA seeking approval for the use of Xarelto (rivaroxaban) to treat patients with deep vein thrombosis (DVT) or pulmonary embolism (PE) and prevention of recurrent venous thromboembolism (VTE).

Janssen Research & Development announced results of the EINSTEIN-PE study showing that Xarelto (rivaroxaban) was comparable to today’s standard of care in treating patients with acute symptomatic pulmonary embolism (PE) and in preventing development of a secondary venous blood clot (known as venous thromboembolism or VTE).

Janssen Research & Development announced that the FDA has assigned a Priority Review designation to its supplemental New Drug Application (sNDA) filed for Xarelto (rivaroxaban) to reduce the risk of thrombotic cardiovascular events in patients with Acute Coronary Syndrome (ACS).

Janssen Research and Development announced that it has submitted a supplemental New Drug Application (sNDA) to the FDA for Xarelto (rivaroxaban) to reduce the risk of thrombotic cardiovascular events in patients with acute coronary syndrome.