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Merck’s Postmarketing Study Delays Prompt FDA To Unsheathe New Enforcement Power

Executive Summary

Januvia and Janumet are misbranded, FDA tells Merck in a warning letter noting that rodent safety studies for the sitagliptin diabetes drugs were 20 months behind schedule. The letter marks the first time FDA has used its FDAAA powers to take enforcement action against a pharma company for such a delay.

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