Merck Gets Warning Letter After Failing to Complete Postmarketing Safety Study
Posted 29 February 2012 | By
Merck Sharp and Dohme Corp.'s global director of regulatory affairs received a warning letter on 17 February from the US Food and Drug Administration warning Merck that it had failed to complete an agreed-upon postmarketing study for its diabetes medications Januvia and Janumet.
The products are now effectively misbranded under the Federal Food, Drug and Cosmetic Act(FD&C Act), and the company faces $250,000 in fines, with further fines accruing for continuing violations.
FDA is demanding that Merck submit a final study protocol for a new 3-month rodent study within 30 days of receipt of the warning letter, with that trial starting within 6 months of receipt of the warning letter.
Merck said in a statement that it is "fully committed to complying with FDA's requirement and is confident that the Company will complete the requirement within the time frame outlined in the February 17 letter."
FDA Warning Letter - Merck Sharp and Dohme Corp. 2/17/12
Merck Provides Information on FDA Post-Marketing Requirement for Sitagliptin