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.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug News
    • Trending
    • Commercial Operations
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Drug Daily Bulletin
    • Drug Industry Daily
  • Device News
    • Trending
    • Commercial Operations
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Device Daily Bulletin
    • FDAnews Device Daily Bulletin Premium
  • Books
    • FDAnews Books Library
    • Drug Books
    • Device Books
  • Training/Events
    • Webinar Training Pass
    • Events
  • Resources
    • Form 483s Database
    • FDA Approved Drugs
    • eCFR and Guidances
    • White Papers
  • CenterWatch
  • About Us
    • The Company
    • Contact Us
  • Advertising
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Australia's TGA Pulls Bufexamac, Citing Serious Skin Reactions

Australia's TGA Pulls Bufexamac, Citing Serious Skin Reactions

September 9, 2020

Australia’s Therapeutic Goods Administration (TGA) has announced that it is revoking drugmaker approvals of 12 first-aid cream products that contain the anti-inflammatory drug bufexamac on Sept. 18 due to the risk of serious skin reactions and will not allow them to be sold in Australia.

Bufexamac is used in combination with chlorhexidine and lidocaine (lignocaine) in first-aid creams for minor cuts, stings and minor burns. There are currently 12 products containing bufexamac registered in Australia.

In addition to the risk of allergic contact dermatitis, the agency said it did not find adequate evidence that the ingredient is effective. The TGA has been investigating the safety of bufexamac since 2011.

View today's stories

Drugs Regulatory Affairs

Upcoming Events

  • 04Apr

    Optimizing Quality Control Operations with Unified Quality

  • 12Apr

    The Participant Playbook Webinar Series, Part 3 — Rethinking the Development of Participant-Centric Clinical Trial Technology

  • 20Apr

    Medical Device Enforcement: Latest Developments from the FDA, DOJ and FTC

  • 25Apr

    Effective Root Cause Analysis and CAPA Investigations for Drugs, Devices and Clinical Trials

  • 26Apr

    FDA’s New Laws and Regulations: What Drug and Biologics Manufacturers Need to Know

  • 26Apr

    Building the Foundation for QMS AI

Featured Products

  • FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

    FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

  • Selecting and Implementing Electronic Document Management Systems in the EU

    Selecting and Implementing Electronic Document Management Systems in the EU

Featured Stories

  • FDA Final Order Requires PMA for Spinal Spheres

  • FDA and Lupus Research Alliance Form Drug Development Consortium

  • GSK and Scynexis Ink Antifungal Licensing Deal Drug

  • FDA Clears Bot Image’s AI Software for Prostate Cancer Screening

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 or Share My Data
Footer Logo

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

Phone 703.538.7600 – Toll free 888.838.5578

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