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J & J Seeking Rivaroxaban Approval

By Drug Discovery Trends Editor | January 7, 2011

Johnson & Johnson said that it requested approval to sell its blood thinner rivaroxaban for the prevention of stroke and embolism in patients with atrial fibrillation.

The company said it filed for marketing approval with the Food and Drug Administration. Atrial fibrillation is a condition in which the upper chambers of the heart contract rapidly and erratically instead of forming a coordinated beat with the two lower chambers. It can cause blood to pool and form clots, which can lead to strokes. Johnson & Johnson said atrial fibrillation patients are five times more likely to have a stroke than other people.

Johnson & Johnson said it also submitted new information about the use of rivaroxaban as a preventive treatment for deep vein thrombosis and pulmonary embolism in patients having hip or knee replacement surgeries. The FDA sent Johnson & Johnson a complete response letter, or a request for more information, in May 2009.

Date: January 6, 2010
Source: Associated Press

 


Filed Under: Drug Discovery

 

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