US-based pharmaceutical company, Merck has received Food and Drug Administration (FDA) approval for its redesigned drug container labels that include a new standardized format to improve readability and provide better information on product.
The 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).
CDER MD, director Janet Woodcock said the 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 project process included a scientific approach to label design, incorporation of feedback received from the FDA and from label surveys and a bundled supplement regulatory approach to ensure that labels were acceptable across CDER’s eight clinical divisions.
The FDA encourages health care providers to report medication errors related to the products included in the Label Standardization Project to its adverse event reporting programme, MedWatch, to better access the impact of the label changes.
Drugs affected by the revisions include Cozaar, Crixivan, Hyzaar, Isentress, Janumet, Januvia, Mevacor, Noroxin, Prinivil, Prinizide, Propecia, Proscar, Singulair, Zocor, and Zolinza.