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
    • FDA Enforcement Actions
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Drug Weekly
    • FDAnews
  • Device News
    • Trending
    • Commercial Operations
    • FDA Enforcement Actions
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Device Weekly
    • FDAnews
  • Books
    • FDAnews Books Library
    • Drug Books
    • Device Books
  • Training/Events
    • Webinar Training Pass
    • Events
    • Webinar Recordings
  • Resources
    • Form 483s Database
    • FDA Approved Drugs
  • CenterWatch
  • About Us
    • The Company
    • FDAnews Editorial Board
    • Contact Us
  • Advertising
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » FDA Approves Ingrezza as First Treatment for Tardive Dyskinesia

FDA Approves Ingrezza as First Treatment for Tardive Dyskinesia

April 13, 2017

Neurocrine Biosciences’ Ingrezza (valbenazine) capsules received the first FDA approval for the treatment of adults with tardive dyskinesia, a movement disorder affecting the mouth, tongue and face. Ingrezza is a selective vesicular monoamine transporter 2 inhibitor.

According to the company, over 20 clinical trials enrolling more than 1,000 patients demonstrated significant improvement in signs and symptoms with Ingrezza compared to placebo through six weeks, with continued reductions observed over 48 weeks of treatment.

The FDA had scheduled an advisory committee meeting for Ingrezza in January, but it canceled that meeting after further review.

Neurocrine says Ingrezza will be available through a select pharmacy network as early as next week, with promotion to healthcare professionals beginning May 1.

View today's stories

Drugs Submissions and Approvals

    Upcoming Events

    • 05Dec

      Thriving in Clinical Research – Overcoming Common Challenges as a Site: Part 3 – Site Resourcing

    • 07Dec

      Proactive Supplier Management Using Quality Agreements

    • 13Dec

      FDA Inspection Overhaul: How Things Have Changed in 2023

    • 14Apr

      MAGI 2024: The Clinical Research Conference

    Featured Products

    • FDA, FTC and DOJ Enforcement of Medical Device Regulations

      FDA, FTC and DOJ Enforcement of Medical Device Regulations

    • Using Real-World Evidence in Drug and Device Submissions

      Using Real-World Evidence in Drug and Device Submissions

    Featured Stories

    • T-cell Malignancy From CAR-T Cell Immunotherapies Gets FDA Investigation

    • Vivos Sleep Apnea Oral Device Gets FDA Nod While Philips Wrestles With Yet Another CPAP Safety Issue

    • Novo Nordisk Battles Wegovy/Ozempic Pretenders and Faces Mounjaro’s Superior Study Results

    • Social, Emotional Risks Associated With Multi-Cancer Screening Discussed by Adcomm

    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