FDA Grants Priority Review of Rivaroxaban

Recently the FDA announced that it was granting a priority review for the anticoagulant medication Rivaroxaban, which is manufactured by Bayer. The review is being conducted for “the additional indication of reducing cardiovascular events in patients with acute coronary syndrome, in conjunction with standard antiplatelet therapy,” according to an article on Medscape.com.

Basically, what this means is that the FDA is going to finish its review within six months of Bayer filing the new drug application (NDA), which is a better alternative to the regular 10-month waiting period that usually occurs. The FDA is also going to be extending Apixaban’s NDA action date by three months. Apixaban is manufactured by Eliquis, Pfizer and Bristol-Myers Squibb. Apixaban is used to prevent strokes for AF patients. All of the drug companies are saying that they are getting the extension because they submitted “additional information about the Eliquis clinical program to the FDA, which constitutes a major amendment to the application and will require additional time for review.”

Apixaban’s ruling should come down on June 28, 2012. Right now, Rivaroxaban is used to treat atrial fibrillation patients by preventing strokes, which are a big concern for AF patients. Other medications used to treat AF include the anticoagulant Multaq. But Multaq has been proven to cause liver failure in some patients and a worsening of the heart condition for others. Some patients have even died while taking Multaq during one clinical trial called the PALLAS study, which is why many doctors have stopped prescribing the drug unless other medications stop working.

If you or a loved one have taken Multaq and developed liver failure or a worsening heart condition, contact the attorneys at Greg Jones today for a free consultation. I am experienced at fighting Multaq lawsuits and may be able to help you recover money for your injuries.

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