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FDA NEWS RELEASE

For Immediate Release: June 10, 2011
Media Inquiries: Morgan Liscinsky, 301-796-0379, morgan.liscinsky@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA approves redesigned labels for some Merck drugs
Changes developed under Merck’s Label Standardization Project

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.

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:

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.

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