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 unapprov
'/>"/>

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

Page: 1 2 3

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:1/15/2014)... , Jan. 15, 2014 The Cadence Fitness & ... Center by the Medical Fitness Association, a non-profit organization ... their full potential. The Cadence Fitness & Health Center ... suburbs and second in the Chicagoland area. ...
(Date:1/15/2014)... YORK , Jan. 15, 2014 ... report is available in its catalogue: ... for Advanced Drug Delivery Systems -- Focus ... STUDY OBJECTIVES ...
(Date:1/14/2014)... (Nasdaq: LMNX ) today announced that it expects ... Monday, February 3, 2014. A press release announcing the results ... (Logo: http://photos.prnewswire.com/prnh/20100104/LUMINEXLOGO ) Management will ... financial results for the fourth quarter and twelve months ended ...
Breaking Medicine Technology:Cadence Fitness & Health Center Certified as Medical Fitness Facility 2Cadence Fitness & Health Center Certified as Medical Fitness Facility 3Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 2Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 3Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 4Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 5Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 6Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 7Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 8Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 9Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 10Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 11Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 12Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 13Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 14Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 15Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 16Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 17Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 18Luminex Corporation Fourth Quarter Earnings Release Scheduled for February 3, 2014 2Luminex Corporation Fourth Quarter Earnings Release Scheduled for February 3, 2014 3
... March 20 Valor Medical, an emerging medical,device company ... human,implant of Neucrylate AN for treatment of cerebral aneurysms ... Tehran. The treatment was under the,guidance of a clinical ... Committee., Dr. Pakbaz stated that the patient,s aneurysm ...
... for more ... anticoagulation patients, INDIANAPOLIS, March ... meter training, equipment and supplies for all long-term,warfarin users who ... The change opens the door to greater convenience and,potentially fewer ...
Cached Medicine Technology:Medicare Announces Expanded Coverage for Warfarin Patients Monitoring Clotting Time at Home 2Medicare Announces Expanded Coverage for Warfarin Patients Monitoring Clotting Time at Home 3Medicare Announces Expanded Coverage for Warfarin Patients Monitoring Clotting Time at Home 4
(Date:7/9/2014)... acute episodes of low back pain are not linked ... wind direction and precipitation. Findings published in Arthritis ... College of Rheumatology (ACR), indicate that the risk of ... or wind gusts, but was not clinically significant. ... everyone experiences low back pain at some point in ...
(Date:7/9/2014)... she had an aneurysm, she figured an invasive brain surgery ... devastated," said Wakulich, who is 56 years old and lives ... diagnosis. Then I met Dr. Bernard Bendok who told me ... It was something I didn,t even know was an option." ... trial to evaluate the safety and effectiveness of the Microvention ...
(Date:7/9/2014)... of stromal support cells and immune cells and ... in the development of diseases could open new ... was the conclusion of a review article by scientists ... Nature . , Prof. Peter Carmeliet: "Consider the ... of cancer cells has been examined in minute detail ...
(Date:7/9/2014)... The Miriam Hospital have found that people with ... depressed have difficulty sticking to a pulmonary rehabilitation ... women, and screening and brief treatment of depression ... study and its findings are published in print ... obstructive pulmonary disease is a common and often ...
(Date:7/9/2014)... NEW YORK (July 8, 2014) Researchers from ... College of Medicine of Yeshiva University will present ... being held July 12 July 17 in Copenhagen, ... triggers that could prompt transition from cognitive normality to ... of the Einstein Aging Study , established in ...
Breaking Medicine News(10 mins):Health News:Low back pain? Don't blame the weather 2Health News:New type of stent could help some brain aneurysm patients 2Health News:Wake-up call for more research into cell metabolism 2Health News:Miriam Hospital study examines effect of depressed mood on pulmonary rehab completion 2Health News:Investigators from Montefiore and Einstein to present data at 2014 Alzheimer's Association International Conference 2Health News:Investigators from Montefiore and Einstein to present data at 2014 Alzheimer's Association International Conference 3
... , BERKELEY HEIGHTS, N.J., Aug. 24 ... provider of secure Health Information Exchange and workflow management services, ... provider of home healthcare services and medical equipment, selected Authentidate,s ... with physicians. , , "We believe that ...
... , Expect the Unexpected - Boost Your ... Aug. 24 New York Blood Center (NYBC) and its regional ... and New Jersey urge healthy people to please donate blood now ... for predictable, as well as unexpected, blood needs. NYBC also ...
... , DOYLESTOWN, Pa., Aug. 24 Medical ... received European CE Mark (Conformite Europeene) approval to commercialize its ... for use in improving coronary artery luminal diameter in patients ... The novel vProtect(TM) Luminal Shield has the potential to change ...
... , , SIGNAL HILL, Calif., ... systems integrator transforming critical care, announced that it has received ... for additional enhancements of the company,s MedEx 1000(TM) "suitcase" intensive ... funds were included in an earlier announcement, we have confirmed ...
... Dr. Mark ... and is giving patients in Texas new reasons to smile. , ... (Vocus) August 24, 2009 -- Mark Sweeney, DDS knows cosmetic dentistry… and ... director of Austin Dental Spa , a practice devoted to turning visits to the dentist ...
... , ... largest primary eye care practice in Delaware, has recently donated eye glasses to the "Unite ... the African nation of Ghana. In the attached photos, residents of Ghana are shown ... ...
Cached Medicine News:Health News:LifeCare Solutions Simplifies Healthcare Order Process Management with Authentidate's Inscrybe Healthcare 2Health News:LifeCare Solutions Simplifies Healthcare Order Process Management with Authentidate's Inscrybe Healthcare 3Health News:LifeCare Solutions Simplifies Healthcare Order Process Management with Authentidate's Inscrybe Healthcare 4Health News:Give Blood Today for Community Preparedness 2Health News:Give Blood Today for Community Preparedness 3Health News:vProtect Luminal Shield (TM) from Prescient Medical Receives CE Mark 2Health News:Integrated Medical Systems Receives $1.1 Million From the U.S. Department of Defense for Critical Enhancements of the World's First 'Suitcase' Intensive Care Unit 2Health News:Integrated Medical Systems Receives $1.1 Million From the U.S. Department of Defense for Critical Enhancements of the World's First 'Suitcase' Intensive Care Unit 3Health News:Austin Texas Cosmetic Dentist Celebrates 30 Years in Practice 2Health News:Austin Texas Cosmetic Dentist Celebrates 30 Years in Practice 3Health News:Simon Eye Associates Donates to "Unite For Sight" Efforts in Ghana 2
Portex® Blue Line® cuffed endotracheal tubes come in a wide selection of sizes, each with a standard 15 mm ISO connector., ,Portex® Blue Line® endotracheal tubes are recognized world...
... PVC. 2 eyes, oral. Marked with ... X-ray opaque line. Graduated. Single use. ... reduce kinking of the tube by ... adapts to the anatomical situation at ...
... Ruschelit® PVC. Murphy eye-oral. High volume/low ... Oral Cuffed Single use. For improved ... of the tube by incorporating a ... cuff. Thermosensitive Ruschelit® PVC adapts to ...
Ruschelit® PVC. Siliconized. Stainless steel spiral reinforced. Murphy eye. High volume/low pressure cuff. Connector is permanently fixed into the tube. X-ray opaque. Graduated. Single use. Steri...
Medicine Products: