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Januvia 'misbranded' as Merck keeps silent on post-marketing violation

This article was originally published in Scrip

Executive Summary

Merck & Co continues to remain silent on why it seems to have become the latest company to have ignored the deadlines imposed by the US FDA for submitting addition information following a for a US FDA post-marketing requirement to conduct a three-month, pancreatic safety study on a diabetic rodent model treated with its first-in-class DPP-4 inhibitor Januvia (sitagliptin).

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