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FDA approves redesigned labels for some Merck drugs

The U.S. Food and Drug Administration announces  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.

 

Merck appreciates the U.S. Food and Drug Administration's (FDA) recognition of our efforts to create new standardized product packaging for several of our medicines (click here for link to news release from FDA). These changes to the packaging of several medicines were made by Merck as a result of comprehensive research conducted directly with pharmacists and pharmacy technicians to understand how the company could help them to further support the accuracy of medication dispensing within the pharmacy.


"Efforts such as this are a part of Merck's overall commitment to help people be well," said Michael Rosenblatt, M.D., chief medical officer for Merck. "We look forward to continuing to work with regulatory agencies and healthcare professionals to implement this new design and help bring the best possible care to patients."


"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.


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.

 

Merck appreciates the U.S. Food and Drug Administration's (FDA) recognition of our efforts to create new standardized product packaging for several of our medicines (click here for link to news release from FDA). These changes to the packaging of several medicines were made by Merck as a result of comprehensive research conducted directly with pharmacists and pharmacy technicians to understand how the company could help them to further support the accuracy of medication dispensing within the pharmacy.

 

"Efforts such as this are a part of Merck's overall commitment to help people be well," said Michael Rosenblatt, M.D., chief medical officer for Merck. "We look forward to continuing to work with regulatory agencies and healthcare professionals to implement this new design and help bring the best possible care to patients."

 

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