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 » FDA GIVES TENTATIVE APPROVAL TO AUROBINDO'S COMBINATION ARV

FDA GIVES TENTATIVE APPROVAL TO AUROBINDO'S COMBINATION ARV

July 11, 2006

The FDA has granted tentative approval to a three-ingredient fixed-dose tablet for use as a stand-alone HIV-1 antiretroviral (ARV) treatment. The product, manufactured by Indian drugmaker Aurobindo Pharma, contains the active ingredients from the ARVs Epivir (lamivudine), Retrovir (zidovudine) and Viramune (nevirapine).

This combination has been shown to be safe and effective in lowering the viral load in HIV-1-infected patients. The recommended regimen for the product involves taking one pill twice daily, following an initial two-week treatment in which each of the components is taken individually.

If approved, the combination treatment will be available for distribution in the U.S. and 15 other countries under the President's Emergency Plan for AIDS Relief (PEPFAR), launched in 2003. The initiative aims to provide $15 billion in HIV/AIDS prevention and treatment programs by 2008.

KEYWORDS FDAnews Drug Daily Bulletin

Upcoming Events

  • 21Jan

    Virtual MDSAP Audits in the Era of COVID-19: What to Know and Do to Pass Virtual Audits

  • 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

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • Purple_Approved_Stamp.gif

    Seno Medical Gets Premarket Approval for Breast Cancer Diagnostic

  • Triple Vaccine, needles

    Moderna to Start New Trial Adding Third Shot of COVID-19 Vaccine

  • Supreme Court Rejects Merck’s Appeal for $2.5 Billion Patent Verdict Reinstatement

  • FDA clears text

    FDA Clears SCC’s Transfusion-Management Software

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