FDA Takes Action to Stop Marketing of Unapproved Time-Released Drug

The U.S. Food and Drug Administration (FDA) recently announced it will take action against companies that market unapproved, time-release drugs--often described as extended-release, long-acting, or sustained-release--that contain guaifenesin, a substance commonly used to relieve cough and cold symptoms to remove mucous from the lungs. The FDA estimates there are 20 such firms selling unapproved products.

"Today's action is another example of our commitment to ensure all drugs marketed in the United States that require FDA approval have that approval," said Steven K. Galson, M.D., M.P.H., director of the FDA's Center for Drug Evaluation and Research (CDER). "This benefits consumers because drugs that skirt the approval process may be unsafe, may not work, and often have inadequate labeling or are improperly manufactured."

This action does not affect products containing guaifenesin in immediate release form. FDA approval is necessary to ensure that the product releases its active ingredients safely and effectively, sustaining the intended effect over the entire time in which the product is intended to work.

Presently, only Adams Respiratory Therapeutics has obtained such FDA approval under the trade names of Mucinex and Humibid.

Companies marketing unapproved products containing guaifenesin in timed-release form are advised to stop manufacturing them within 90 days and cease shipping them in interstate commerce within 180 days. After these dates, companies wishing to market products containing guaifenesin in timed-release form must obtain approval or face regulatory action.

For more information, visit FDA's Unapproved Drugs Web site at www.fda.gov/cder/drug/unapproved_drugs/default.htm.

Download Center

HTML - No Current Item Deck
  • Free Safety Management Software Demo

    IndustrySafe Safety Management Software helps organizations to improve safety by providing a comprehensive toolset of software modules to help businesses identify trouble spots; reduce claims, lost days, OSHA fines; and more.

  • The Top 5 Safety and Technology Trends to Watch in 2019

    Get the latest on trends you can expect to hear more about in 2019, including continued growth of mobile safety applications, wearable technology, and smart PPE; autonomous vehicles; pending OSHA recordkeeping rulemaking; and increased adoption of international safety standard, ISO 45001.

  • Get the Ultimate Guide to OSHA Recordkeeping

    OSHA’s Form 300A posting deadline is February 1! Are you prepared? To help answer your key recordkeeping questions, IndustrySafe put together this guide with critical compliance information.

  • Safety Training 101

    When it comes to safety training, no matter the industry, there are always questions regarding requirements and certifications. We’ve put together a guide on key safety training topics, requirements for certifications, and answers to common training questions.

  • Conduct EHS Inspections and Audits

    Record and manage your organization’s inspection data with IndustrySafe’s Inspections module. IndustrySafe’s pre-built forms and checklists may be used as is, or can be customized to better suit the needs of your organization.

  • Industry Safe

OH&S Digital Edition

  • OHS Magazine Digital Edition - January 2019

    January 2019

    Featuring:

    • PREVENTING ERRORS
      Production vs. Safety 
    • EMERGENCY SHOWERS & EYEWASH
      Meeting the Requirements for Emergency Equipment
    • CONSTRUCTION SAFETY
      The State of Contractor Safety
    • FOOT PROTECTION
      The Three Keys to Effective Chemical Management
    View This Issue