Navigation Links
FDA Prompts Removal of Unapproved Drugs From Market
Date:3/2/2011

SILVER SPRING, Md., March 2, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today took action against companies that manufacture, distribute, or market certain unapproved prescription oral cough, cold, and allergy products. The affected products cannot be legally marketed in the United States.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

Unapproved prescription cough, cold, and allergy drug products have not been evaluated by the FDA for safety, effectiveness, and quality. People may be at greater risk when using these products than when using FDA-approved prescription drugs or drugs that are appropriately marketed over-the-counter (OTC).  

Many health care providers are unaware of the unapproved status of drugs and have continued to unknowingly prescribe them because the drugs' labels do not disclose that they lack FDA approval.

"Removing these unapproved products from the market will reduce potential risks to consumers," said Deborah Autor, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research.  "There are many FDA-approved prescription products, as well as appropriately marketed over-the-counter products, available to treat cough, cold, and allergy symptoms; so, we expect little or no negative impact on consumers from the removal of these unapproved products."  

Companies that have previously listed products subject to today's action with FDA are expected to stop manufacturing them within 90 days and stop shipping the products within 180 days.  Companies that have not previously listed products subject to today's action with FDA are expected to stop manufacturing and shipping their products immediately.

Given that so many cough, cold, and allergy drug products exist that are FDA-approved prescription products or are appropriately marketed OTC, taking an unapproved prescription product is an unnecessary risk.  

Consumers who believe they are taking an unapproved prescription cough, cold, or allergy product should contact their health care provider to discuss alternatives.  

This is the 17th action on a drug class as part of FDA's Unapproved Drugs Initiative, which began in June 2006.  The initiative is the agency's risk-based enforcement approach to efficiently and rationally bring all unapproved new drugs into the approval process.  One of the goals of the initiative is to reduce consumer exposure to drugs that are not proven safe, effective, and of high quality.  

Consumers and health care professionals are encouraged to report adverse side effects or medication errors from the use of unapproved prescription cough, cold, and allergy products to the FDA's MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 800-332-1088.


Media Inquiries: Shelly Burgess, 301-796-4651; shelly.burgess@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Leading Denture Cream Litigation Firm Welcomes GSK Announcement of Removal of Zinc From Its Denture Creams
2. Romeo and Juliette Laser Hair Removal Is First Center in New York City to Own Cynosures New Elite MPX(TM) Laser System
3. WIFH Atlanta Announces Breakthrough Technique in Laser Hair Removal for Ethnic Skin Types
4. Myelin Removal Beads: Premium Efficiency for Neural Cell Separations and Antibody Stainings
5. AUA Guideline: Full Kidney Removal Not Necessary for All Kidney Tumors
6. Gallbladder Removal Through Vagina Offers Minimally Invasive Alternative
7. September 2008 Mayo Clinic Health Letter Highlights Cataract Removal, Severe Headache and Dual Energy X-Ray Imaging
8. Novare Announces Completion of First Pediatric Single Port Spleen Removal Using RealHand(R) HD Instruments
9. Applisonix Announces Breakthrough in Ultrasound Technology for Hair Removal - Average Hair Reduction of 38% Following Initial Treatment
10. FDA Consumer Health Information - FDA Tightens Reins on Unapproved Chelation Drugs
11. FDA Issues Warnings to Marketers of Unapproved Chelation Products
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/29/2017)... EAST HANOVER, N.J. , March 29, 2017 ... and Drug Administration (FDA) has accepted the company,s ... review for CTL019 (tisagenlecleucel-T), an investigational chimeric antigen ... refractory (r/r) pediatric and young adult patients with ... first BLA submission by Novartis for a CAR-T. ...
(Date:3/29/2017)... 2017 Research and Markets has announced ... - 2025" report to their offering. ... The global orthopedic ... by 2025. Increasing geriatric population prone to orthopedic diseases is ... systems over the forecast period. Osteoarthritis and osteoporosis are most ...
(Date:3/29/2017)... WALNUT CREEK, Calif. , Mar 29, 2017 ... tissue-sparing, cervical-fusion technology, announced the addition of two ... Scott Lynch has joined the company to ... is assuming International leadership.  Together, Mr. Lynch and ... industry experience.  Mr. Lynch joins ...
Breaking Medicine Technology:
(Date:3/30/2017)... WASHINGTON, DC (PRWEB) , ... March 30, 2017 ... ... Truth. , On the eve of Autism Awareness Month, representatives from Organic ... Center, World Mercury Project, Focus For Health Foundation, A Voice for Choice, Moms ...
(Date:3/30/2017)... ... March 30, 2017 , ... Nutrition Education ... and Dietetics (AND), will join nonprofit Seafood Nutrition Partnership (SNP) in presenting “Eating ... designed to help nutrition educators and students inform consumers about the health benefits ...
(Date:3/30/2017)... ... March 30, 2017 , ... ... letter to President Trump expressing their support for an independent Vaccine Safety Commission. ... scientists and one medical journalist, will hold a press conference at 9:00 ...
(Date:3/29/2017)... WI (PRWEB) , ... March 29, 2017 , ... ARI ... its exclusive provider of co-op eligible dealer websites for its network of more than ... of professional landscaping and agricultural equipment including rotary and flail mowers and cutters, rear ...
(Date:3/29/2017)... ... March 29, 2017 , ... ... professional squash, announced it has enlisted New York City-based sports and entertainment marketing ... develop and procure sponsorship opportunities for the Professional Squash Association (PSA), which includes ...
Breaking Medicine News(10 mins):