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
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here