Rivaroxaban Gains FDA Indications For The Treatment And Prevention Of DVT And PE Reply

The FDA today expanded the indication for rivaroxaban (Xarelto, Johnson & Johnson) to include the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and to reduce the risk of recurrent DVT and PE.

The oral anticoagulant is already approved to reduce the post-surgical risk of DVT and PE  after hip and knee replacement surgery and to reduce the risk of stroke in people with atrial fibrillation. The new indication was granted under the FDA’s priority review program.

“Xarelto is the first oral anti-clotting drug approved to treat and reduce the recurrence of blood clots since the approval of warfarin nearly 60 years ago,” said Richard Pazdur,  director of the FDA’s Office of Hematology and Oncology Products, in an FDA press release.

Click here to read the FDA press release…

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