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Xarelto Granted Priority Review by FDA

August 3, 2017


Video Transcription


Tighe Wilhelmy with Velawcity here to discuss some of the latest news related to Xarelto and the Federal Drug Administration (FDA).


On June 28th, 2017 the FDA granted priority review for Xarelto’s once-daily 10mg blood thinner, for purposes of reducing the risk of recurrent Venous Thromboembolism, which often includes Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE). Jannsen Research believes the 10mg doseage will help physicians customize treatment plans and manage patients over time.


Priority reviews are granted for medicines that may offer significant improvements to diagnoses, treatment or prevention of a serious condition. It reduces the review period from (10) months to (6) months. The agency’s new action date is October 28th, 2017.  


All of this in the midst of the 18,000 pending actions against Xarelto, including both state and federal court.


For more information regarding pharmaceutical drug or medical device lawsuits, please visit our website or call (480) 970-1180 to speak with a representative. I’m Tighe Wilhelmy with Velawcity and thank you for watching.


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