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Merck redesigned drug container labels receive FDA approval

Merck has received the US Food and Drug Administration (FDA) approval for its redesigned drug container labels in its Label Standardization Project.

Merck’s Label Standardization Project includes 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 include a scientific approach to label design through Human Factors Engineering and Usability Studies, incorporation of feedback received from the FDA and from label surveys.

The process also includes a bundled supplement regulatory approach to ensure that labels were acceptable across Center for Drug Evaluation and Research (CDER)’s eight clinical divisions.

Under the Merck’s project the FDA’s CDER revised 34 container labels for 16 solid oral drug products.

CDER revised drugs include Cozaar, Crixivan, Hyzaar, Isentress, Janumet, Januvia, Mevacor, Noroxin, Prinivil, Prinizide, Propecia, Proscar, Singulair, Zocor and Zolinza.

CDER director Janet Woodcock said they are hopeful that Merck’s new standardized labels will aid in reducing pharmacy selection errors.