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 APPROVES PREZISTA FOR RESISTANT HIV INFECTIONS

FDA APPROVES PREZISTA FOR RESISTANT HIV INFECTIONS

July 3, 2006

The FDA has approved a new drug for adults whose HIV infection has not responded to treatment with other antiretroviral drugs.

Prezista (darunavir), a new HIV protease inhibitor, is approved to be co-administered with a low-dose of ritonavir and other active anti-HIV agents. Ritonavir, a protease inhibitor approved in 1996, slows the breakdown of Prezista in the body, thereby increasing the concentration of Prezista in the patient's system.

Prezista is manufactured for Tibotec, a division of Ortho Biotech Products.

Infection with HIV causes AIDS, which results in more than 15,000 premature deaths each year in the United States and more than 2.8 million deaths each year worldwide.

The accelerated approval is based on evidence from two randomized, controlled studies comparing the safety and effectiveness of a Prezista-ritonavir combination with other ritonavir-boosted protease inhibitor combinations. Patients in both arms of the trials also used other anti-HIV agents (nucleoside reverse transcriptase inhibitors) with or without enfuvirtide, a fusion inhibitor that inhibits the virus from entering the cell.

KEYWORDS FDAnews Drug Daily Bulletin

Upcoming Events

  • 19Jan

    Pharmaceutical Quality Risk Management: Navigating the Intersection Between Regulatory Requirements & Risk Management

  • 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

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • Regeneron logo

    U.S. Government Orders More Supplies of Regeneron’s COVID-19 Antibody Cocktail

  • Siemens Healthineers logo

    Siemens Healthineers COVID Test Gets Additional Sampling Method Clearance

  • COVID-19  Clinical Trial

    Synairgen Initiates Dosing in Late-Stage Trial of Inhaled COVID-19 Therapy

  • Verona Pharma logo

    Verona Pharma Ends Enrollment in Inhaler-Administered COVID-19 Drug Pilot

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