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
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
26%
Attracting a skilled workforce
29%
Obtaining/maintaining adequate financing
14%
Regulatory compliance
31%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Report: Pfizer Makes $101 Billion Offer to AstraZeneca
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here