FDA Seeks Clarity On DPP-4 Class Safety Signals With Linagliptin Post-Market Requirements
This article was originally published in Pharmaceutical Approvals Monthly
Executive SummaryFDA is using the post-marketing study requirements for Boehringer Ingelheim GmbH's Tradjenta (linagliptin) to investigate some of the emerging safety concerns about the DPP-4 inhibitor class.
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Each month, Pharmaceutical Approvals Monthly analyzes the FDA review process for a recent approval based on the NDA or BLA review documents. A detailed chronology of product development and listing of key reviewers accompany each profile.