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
  • Resources
    • Form 483s Database
    • FDA Approved Drugs
    • White Papers
  • CenterWatch
  • About Us
    • The Company
    • FDAnews Editorial Board
    • Contact Us
  • Advertising
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » ADMA Relaunches Bivigam After Three Year Interruption

ADMA Relaunches Bivigam After Three Year Interruption

August 28, 2019

ADMA Biologics relaunched its immunodeficiency drug Bivigam (immune globulin intravenous) after resolving production problems at its facility in Boca Raton, Florida that kept the product off the market for almost three years.

The FDA originally approved the firm’s biologics license application in 2012, but prevented a launch following production snags at a contract manufacturer acquired by ADMA. The agency  granted approval for the “optimized” facility in May of this year.

The company said the relaunch will help alleviate shortages of immune globulin that have plagued U.S. hospitals since last year.

View today's stories

Drugs Regulatory Affairs

    Upcoming Events

    • 28Sep

      The Cost of Counterfeiting: Why You Need a Plan to Secure Your Medical Device Supply Chain

    • 28Sep

      Calculating Sample Size to Satisfy FDA Expectations

    • 11Oct

      GMP Quality Management vSummit 2023: Where Quality Meets Risk

    • 16Oct

      MAGI@home Clinical Research Conference 2023

    • 26Oct

      FDA in 2024: What to Expect in an Election Year

    • 08Nov

      18th Annual FDA Inspections vSummit

    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

    • Culture of Quality and Compliance Go Hand in Hand, Says Expert

    • First-in-Human Studies of Artificial Wombs Subject of FDA’s Adcomm This Week

    • BCBS of Louisiana Sues Celgene, BMS for Patent Fraud of Blockbuster Drug Pomalyst

    • AI/ML Data Collection Needs to Avoid Bias, FDA Dep. Director Says

    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