Navigation Links
FDA Approves Redesigned Labels for Some Merck Drugs
Date:6/10/2011

SILVER SPRING, Md., June 10, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today is announcing the approval of Merck's redesigned drug container labels that include a new standardized format to improve readability and provide better information on product and strength differentiation.

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

Merck's Label Standardization Project includes the revision of 34 container labels for 16 solid oral drug products regulated by the FDA's Center for Drug Evaluation and Research (CDER). Drugs affected by the revisions include: Cozaar, Crixivan, Hyzaar, Isentress, Janumet, Januvia, Mevacor, Noroxin, Prinivil, Prinizide, Propecia, Proscar, Singulair, Zocor, and Zolinza.

"We commend Merck for their efforts," said Janet Woodcock, M.D., director of CDER. "This was no small undertaking, and we are hopeful that Merck's new standardized labels will aid in reducing pharmacy selection errors."

Merck's project included evaluating the proposed label content and layout, selecting new packaging design, and obtaining regulatory approval to implement the new packaging design. The Label Standardization Project process included:

  • a scientific approach to label design through Human Factors Engineering and Usability Studies;
  • incorporation of feedback received from the FDA and from label surveys;
  • a bundled supplement regulatory approach to ensure that labels were acceptable across CDER's eight clinical divisions.

To better access the impact of these label changes, the FDA encourages health care providers to report medication errors related to the products included in Merck's Label Standardization Project to MedWatch, the FDA's adverse event reporting program.

For more information:

MedWatch, the FDA's adverse event reporting program

http://www.fda.gov/Safety/MedWatch/default.htm

How to Report a Medication Error

http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Morgan Liscinsky, 301-796-0379, morgan.liscinsky@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. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
2. Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV
3. FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder
4. European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
5. FDA Approves MiddleBrooks Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
6. FDA Approves XYZAL(R) (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
7. UM Maryland Industrial Partnerships Program Approves 18 Collaborative Research Projects, Worth $4.4 Million, Between University Faculty, State Technology Companies
8. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
9. U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
10. FDA Approves HIFU Clinical Trial for Recurrent Prostate Cancer
11. EPA Approves XDS-CALUX(R) as Alternate Dioxin Test Method 4435
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/24/2017)... NEW YORK , Feb. 24, 2017 ... Monteverde & Associates PC , a boutique securities ... New York City , announces that a ... of Massachusetts  against Inotek Pharmaceuticals ... purchasers of the Company,s securities between July 23, 2015 and ...
(Date:2/24/2017)... Australien, 24. Februar 2017 ITL Limited, ... des Gesundheitsbereiches, ist erfreut, für das zum 31. ... entsprechenden Vorjahreszeitraum exzellente Ergebnisse vorlegen zu können. Eine ... zum Wachstum" finden Sie hier . ... nach Steuern 2,12 Millionen USD (Dez. 2015: 1,04 Millionen USD; +104 %) ...
(Date:2/24/2017)... 2017  This report analyzes the worldwide markets for ... Products: Intermediates, Analytical, and Others. The End ... and Agrochemicals. The report provides separate comprehensive analytics for ... Europe , and Rest of World. Annual estimates ... 2022. Also, a six-year historic analysis is provided for ...
Breaking Medicine Technology:
(Date:2/24/2017)... ... 24, 2017 , ... Healthcare Associates of McKinney announced today that ... at 8080 State Highway 121, Suite 210, McKinney, Texas 75070. It is in ... , As the practice has grown, the need for more space has been paramount. ...
(Date:2/24/2017)... ... February 24, 2017 , ... The International Association of Eating Disorders Professionals ... What You See” body image mannequin art competition. Selected from 15 submissions from around ... winner revealed at the 31st annual iaedp Symposium, March 22 – 26 in Las ...
(Date:2/24/2017)... ... 24, 2017 , ... Castle Farms, the celebrated Northern ... with the winning couple announced on Feb. 14, 2017, on Facebook. The free ... vendors: A Matter of Taste, Ryan Rousseau Enterprises, A Touch of Spring and ...
(Date:2/23/2017)... ... 2017 , ... Rare Disease Report®, which is the only ... Disease Day events, hosted by the Rare Disease Legislative Advocates (RDLA) on February ... e-newsletter and quarterly publication, will be conducting interviews with patients and advocates in ...
(Date:2/23/2017)... ... February 23, 2017 , ... EBSCO Information Services ... Institute for Health and Care Excellence (NICE) framework. The agreement allows purchasers ... (NHS) to search, order and purchase medical and healthcare-related content through GOBI ...
Breaking Medicine News(10 mins):