We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Device Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Roche’s Xofluza Secures EU Authorization

Roche’s Xofluza Secures EU Authorization

January 13, 2021

Roche’s new influenza treatment and preventative drug, Xofluza (baloxavir marboxil), has been approved by EU regulators.

The drug is indicated to treat uncomplicated influenza in patients age 12 and up or to prevent influenza in individuals following contact with someone infected with the virus. The approval was based on positive results from three phase 3 studies.

Xofluza is a “prodrug” that is metabolized in the body as an enzyme inhibitor that blocks the viral life cycle. Roche said the approval “marks the first innovation in mechanism of action for an influenza antiviral” approved by the European Commission in almost 20 years.

View today's stories

Pharmaceuticals Submissions and Approvals

Upcoming Events

  • 27Jan

    Medical Device Clinical Trials in China: Latest Regulatory Developments

  • 27Jan

    FDA’s Response to COVID-19: Fundamentals of Obtaining Emergency Use Authorizations

  • 09Feb

    Maintaining Your Risk-Based Cleaning and Disinfectant Programs: Best Practices During COVID-19

  • 10Feb

    FDA Under the Biden Administration: What’s to Come and What It Will Mean

  • 11Feb

    Lab X.0: Addressing Quality and Compliance Challenges in Laboratory Operations in the COVID-19 All-Digital Era

  • 17Feb

    Effective Auditing for Manufacturing Quality

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • Regeneron logo

    Regeneron’s Antibody Cocktail Shows Efficacy as COVID-19 Treatment

  • Mobile apps client cellphone cell phone

    FDA to Review Berkshire’s 510(k) Submission for Remote Drug-Delivery System

  • COVID-19

    Desidustat Improves Oxygenation for Hospitalized COVID-19 Patients

  • abbott-logo.gif

    Abbott’s Panbio COVID-19 Test Gets Additional CE Marks

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

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

Phone 703.538.7600 – Fax 703.538.7676 – Toll free 888.838.5578

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing