Levaquin Approval For Plague Carries Just One Postmarketing Requirement
This article was originally published in The Pink Sheet Daily
Study requirement for J&J’s antibiotic is less onerous than the studies that were imposed for the two other products approved under the Animal Rule.
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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.