Merck revises labels for 16 drugs

SILVER SPRING, Md. — The Food and Drug Administration has approved changes to the labels of several drugs made by Merck, the agency said Friday.

Merck’s Label Standardization Project includes the revision of 34 container labels for 16 drugs, all orally administered pills. These include the cardiovascular drugs Cozaar (losartan) and Hyzaar (losartan and hydrochlorothiazide), the diabetes drugs Januvia (sitagliptin) and Janumet (sitagliptin and metformin), the allergy and asthma drug Singulair (montelukast), the HIV drug Isentress (raltegravir) and others.

“We commend Merck for their efforts,” FDA Center for Drug Evaluation and Research director Janet Woodcock said. “This was no small undertaking, and we are hopeful that Merck’s new standardized labels will aid in reducing pharmacy selection errors.”

The project included evaluating proposed label content and layout, selecting new packaging design and getting approval from the FDA.

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