• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » FDA approves XARELTOR

FDA approves XARELTOR

November 7, 2011
CenterWatch Staff

The FDA has approved XARELTOR to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. XARELTOR is the only oral anticoagulant approved in the U.S. that offers once-daily dosing, without
the need for routine blood monitoring.

XARELTOR is approved to reduce the risk of stroke and systemic embolism in
patients with nonvalvular atrial fibrillation at a dose of 20 mg once daily, or 15 mg once daily for patients with moderate to severe renal impairment, taken with the evening meal. There are limited data on the relative effectiveness of XARELTOR and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well-controlled.

The approval of XARELTOR was based on the pivotal, double-blind phase III ROCKET AF (Rivaroxaban once-daily oral direct factor Xa inhibition compared with vitamin K antagonism for the prevention of stroke and embolism trial in atrial fibrillation) global clinical trial, in which once-daily rivaroxaban effectively reduced the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, with major bleeding rates comparable to warfarin. In bleeding categories of great concern, such as bleeding into a critical organ and fatal bleeding, fewer events were observed with rivaroxaban. In the categories of transfusions and gastrointestinal bleed, more events were observed with rivaroxaban.

Upcoming Events

  • 16Feb

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

  • 21May

    WCG MAGI Clinical Research Conference – 2023 East

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • Revamp-360x240.png

    Califf Calls for Major Evidence Generation Revamp, Experts’ Opinions Differ

  • AskTheExpertsGreen-360x240.png

    Ask the Experts: Managing Investigational Products

  • SurveywBlueBackground-360x240.png

    Survey Outlines Site Challenges, Successes on Diversity

  • PatientCentricity-360x240.png

    Site Spotlight: DM Clinical Shows Patient Centricity Doesn’t Have to Break the Bank

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell or Share My Data

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing