Supplier News Breaks Archives
Merck Rx label redesign gets FDA OK
June 13th, 2011
SILVER SPRING, Md. – The Food and Drug Administration has approved redesigned drug container labels from Merck.
The FDA said late last week that the revamped labels feature 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), according to the agency
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," stated 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, the FDA said, included evaluating the proposed label content and layout, selecting new packaging design, and obtaining regulatory approval to implement the new packaging design.