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 » Health Canada Approves ALK’s Ragweed Allergy Tablet

Health Canada Approves ALK’s Ragweed Allergy Tablet

December 28, 2020

ALK has received Health Canada approval for Ragwitek (standardized allergen extract, short ragweed (ambrosia artemisiifolia sublingual tablet) for treating moderate-to-severe ragweed pollen allergies in children aged five and up.

The once-daily tablet’s approval stemmed in part from positive data from a phase 3, 1,022-participant trial of children and adolescents with ragweed allergic rhinitis and conjunctivitis, the largest study to date, according to the company.

The study found that Ragwitek significantly improved symptoms in patients aged five to 17 and decreased medication use compared to placebo, with a strong level of tolerance and a low level of discontinuation rates due to adverse events.

View today's stories

Pharmaceuticals Submissions and Approvals

Upcoming Events

  • 26Jan

    Reducing Complexity in Starting Clinical Trials – More Patients, Faster Startup

  • 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

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • CE mark

    MiRXES Earns CE Mark for COVID-19/Flu Test

  • KitePharma_Logo

    Kite Pharma’s Tecartus Gains UK Recommendation for Lymphoma

  • Eli Lilly logo

    Lilly’s Monoclonal Antibody Could Prevent COVID-19 in the Elderly

  • CE mark

    Fluidigm Gains CE Mark for Saliva-Based Assay for COVID-19

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