Merck receives FDA approval for redesigned drug container labels

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.