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
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
29%
Breakthrough designations
10%
Protecting the supply chain
43%
Expedited reviews of drug submissions
10%
More stakeholder involvement
10%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here