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J&J Says FDA Denies New Xarelto Application

From Associated Press (March 5, 2013)

NEW YORK -- Johnson & Johnson said Monday that regulators have again refused to grant a new marketing approval to its anticlotting drug Xarelto.

The company has asked the Food and Drug Administration to approve Xarelto for reducing the risk of heart attack and other cardiovascular problems in patients with acute coronary artery disease. That’s a condition in which a narrowed blood vessel reduces flow to the heart muscle, increasing the risk of heart attack and other catastrophic problems.

This is the second time the FDA has refused to grant the approval. FDA advisers have expressed concerns about bleeding side effects linked to the pill. Patients taking Xarelto were three times more likely to have major internal bleeding, compared with patients taking other blood thinners.

Johnson & Johnson said it will work to address the FDA’s questions.

The FDA has already approved Xarelto as a treatment for deep vein thrombosis and pulmonary embolism, for reducing the risk of strokes in some patients with atrial fibrillation, and for reducing the risk of blood clots in the legs and lungs of people who have had hip or knee replacement surgery.

Shares of Johnson & Johnson rose 41 cents to $77.61 in morning trading.


Posted: March 2013