FDA to Take Action Against Companies Marketing Unapproved Guaifenesin Products - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

FDA to Take Action Against Companies Marketing Unapproved Guaifenesin Products


ePT--the Electronic Newsletter of Pharmaceutical Technology

Untitled Document

Rockville, MD (May 25)—The US Food and Drug Administration (www.fda.gov) issued a statement announcing its intention to take action against companies that market unapproved timed-release drug products that contain guaifenesin. Guaifenesin stimulates the removal of mucous from the lungs and is used in medications to relieve cough and cold symptoms.

According to FDA, approximately 20 firms manufacture timed-release products containing guaifenesin that have not undergone FDA review. Drugs that have not been reviewed by FDA are considered unapproved and can pose a threat to consumers. “Drugs that skirt the approval process may be unsafe, may not work, and often have inadequate labeling or are improperly manufactured,” says Steven K. Galson, the director of FDA’s Center for Drug Evaluation and Research in the statement issued by FDA.

Only one company, Adams Respiratory Therapeutics (Chester, NJ, www.adamsrt.com) currently has FDA approval for timed-release products containing guaifenesin. The products are sold under the trade names of “Mucinex” and “Humibid.” Adams is applauding FDA’s move against those marketing unapproved products.

FDA ordered companies marketing the unapproved products to stop manufacturing them within 90 days and to cease shipping them within 180 days. Those companies that wish to continue marketing the products must obtain FDA approval.  The full text of FDA’s statement can be found here.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
23%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
7%
All of the above.
47%
No government involvement in patient treatment or drug development.
9%
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here