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

0

GOOD

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:5/24/2013)... -- Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL ) today ... Bank Health Care Conference to be held May 29-30 ... Adrian Adams , Chief Executive Officer and President, ... and its product pipeline at 12:00 p.m. ET on ... http://photos.prnewswire.com/prnh/20101202/MM10881LOGO ) The presentation will also be ...
(Date:5/24/2013)... , May 24, 2013  Sinovac Biotech ... provider of biopharmaceutical products in China ... operating subsidiary company of Sinovac, obtained the Certificate ... Certificate) from the China State and Food Administration ... bulk production plants, and its Changping filing and ...
(Date:5/24/2013)... GARDEN CITY, England and ... Heptares Therapeutics, the leading GPCR drug discovery and development company, is ... Usui as a Consultant to augment the Company,s business ... territories. Mr Usui has more than 15 years of ... industry including senior roles at Perlegen Sciences, Inc., Roche Pharma ( ...
Breaking Medicine Technology:Auxilium Pharmaceuticals, Inc. To Present At The Deutsche Bank Health Care Conference 2Auxilium Pharmaceuticals, Inc. To Present At The Deutsche Bank Health Care Conference 3Auxilium Pharmaceuticals, Inc. To Present At The Deutsche Bank Health Care Conference 4Sinovac Beijing Obtains China GMP Certificate Under the New GMP Guidelines 2Sinovac Beijing Obtains China GMP Certificate Under the New GMP Guidelines 3Heptares Augments Business Development Capabilities in Japan and Other Asian Territories 2
... Announces Preliminary Top-Line Positive Data from taliglucerase alfa Switchover Trial -- CARMIEL, Israel, Nov. 2, 2010 ... ... if (typeof(lpUnit)==,undefined,) var lpUnit=,PRN,; --> ... var shortURL = ""; BitlyCB.alertResponse = function(data) { var s = ,; var first_result; // Results are keyed by ...
... Nov. 1, 2010 More than half of the ... Fund portfolio have received notices of funding through the ... Protection and Affordable Care Act of 2010. ... FAST, GRest, Pericardial Access and SonarMed all learned today ...
Cached Medicine Technology:Protalix BioTherapeutics Announces Preliminary Top-Line Positive Data from taliglucerase alfa Switchover Trial 2Protalix BioTherapeutics Announces Preliminary Top-Line Positive Data from taliglucerase alfa Switchover Trial 3Protalix BioTherapeutics Announces Preliminary Top-Line Positive Data from taliglucerase alfa Switchover Trial 4Protalix BioTherapeutics Announces Preliminary Top-Line Positive Data from taliglucerase alfa Switchover Trial 5Protalix BioTherapeutics Announces Preliminary Top-Line Positive Data from taliglucerase alfa Switchover Trial 6Protalix BioTherapeutics Announces Preliminary Top-Line Positive Data from taliglucerase alfa Switchover Trial 7Protalix BioTherapeutics Announces Preliminary Top-Line Positive Data from taliglucerase alfa Switchover Trial 8Protalix BioTherapeutics Announces Preliminary Top-Line Positive Data from taliglucerase alfa Switchover Trial 9Protalix BioTherapeutics Announces Preliminary Top-Line Positive Data from taliglucerase alfa Switchover Trial 10Indiana Life Sciences Start Ups Garner More than $1.5 Million in Competitive Federal Funding 2
(Date:5/25/2013)... May 25, 2013 Communities of Distinction ... It is the fifth largest media market in the United ... number one visitor destination in Texas and a major convention ... the American West as it is home to many major ... enjoy from sports to the arts. Residents and locals will ...
(Date:5/25/2013)... 25, 2013 Actos lawsuit ... U.S. District Court, Western District of Louisiana, continue to ... a Case Management Order issued on May 21st, the ... contested motions in the Actos bladder cancer litigation, as ... Actos Product Liability Litigation, MDL No. 2299) , “We ...
(Date:5/25/2013)... great companions for senior citizens, but elderly people who always ... likely to crash than those who never drive with a ... licensed drivers aged 70 and older. The nearly 700 participants ... their pet in the car. Among those who always ... high as among those who never drove with their pet. ...
(Date:5/25/2013)... United States (PRWEB) May 25, 2013 ... and largest underground shelter company in the US ... composite underground structures for over 35 years. M.E. ... PROTECTION, U.S. Handbook of NBC Weapon Fundamentals and ... the United States’ bible on shelter engineering. McCarthy ...
(Date:5/25/2013)... 25, 2013 Providing patients with their best ... team of weight management professionals. But, aside from educating patients ... Diet Doc’s hCG diets also provide patients, who ... childhood like bullying, more control over their lives by achieving ... with the underlying factors of weight gain derived from earlier ...
Breaking Medicine News(10 mins):Health News:Communities of Distinction TV Presents May Air Dates for Dallas-Ft. Worth, Texas 2Health News:Actos Lawsuit News: Bernstein Liebhard LLP Notes New Case Management Order in Federal Actos Bladder Cancer Litigation 2Health News:Actos Lawsuit News: Bernstein Liebhard LLP Notes New Case Management Order in Federal Actos Bladder Cancer Litigation 3Health News:Seniors More Likely to Crash When Driving With Pet: Study 2Health News:Radius Engineering International Inc. Offers Tools to Stay Safe and Recover From Any Disaster 2Health News:Radius Engineering International Inc. Offers Tools to Stay Safe and Recover From Any Disaster 3Health News:hCGTreatments / Diet Doc hCG Diets & Weight Loss Plans Announces hCG Diet Plans for Those Suffering from Abuse-Related Weight Gain 2Health News:hCGTreatments / Diet Doc hCG Diets & Weight Loss Plans Announces hCG Diet Plans for Those Suffering from Abuse-Related Weight Gain 3
... something that Dr. David Williams has been questioning since 1992. , ... ... PSA test -- in both predicting cancer and saving lives -- was ... Times. The reliability of this test is something that Dr. David ...
... Sisters take on nursing medical malpractice challenge by ... Their Product RNReport card introduces standardized shift reporting ... organized in their day to day tasks.RNReport Card ... and shift reporting process. It fits conveniently in ...
... tool aimed at rapid employee development of on-the-job performance. Human ... accelerate their development. RapidEcho provides an evidence based method for ... for personal improvement. , ... Sydney, ...
... therapy to decrease testosterone levels increase their risk of ... who do not take these medications, according to a ... of CANCER , a peer-reviewed journal of the ... and careful scrutiny of patients, health can keep men ...
... LINTHICUM, MD, April 27, 2009The American Urological Association (AUA) ... recent recommendations issued by other major groups about ... test should be offered to well-informed, men aged 40 ... at least 10 years. The PSA test, as well ...
... cutting services and staff, while more patients are in ... out of ten hospitals nationally are seeing a greater ... departments, according to a new survey from the American ... half of hospitals reported they have cut staff. ...
Cached Medicine News:Health News:Dr. David Williams Scoops National Media on PSA Effectiveness -- by 17 Years 2Health News:RN Sisters Bring Low-Tech Innovations to New Nurses and Nursing Students 2Health News:PeopleStreme Releases RapidEcho Online Tool for Employee Personal Development 2Health News:PeopleStreme Releases RapidEcho Online Tool for Employee Personal Development 3Health News:Prostate cancer therapy increases risk of fractures and cardiovascular-related death 2Health News:AUA counters mainstream recommendations with new best practice statement on PSA testing 2Health News:AUA counters mainstream recommendations with new best practice statement on PSA testing 3Health News:AUA counters mainstream recommendations with new best practice statement on PSA testing 4Health News:Economic Downturn Taking Toll on Patients and Communities Hospitals Serve: New Survey Finds 2Health News:Economic Downturn Taking Toll on Patients and Communities Hospitals Serve: New Survey Finds 3
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
Medicine Products: