FDA Approves Boxed Warning On Cancer Risk For Elidel And Protopic
This article was originally published in The Pink Sheet Daily
Executive Summary
The agency finalized the addition of the boxed warnings and revised indications for the eczema therapies' labels one year after a similar recommendation by an FDA advisory committee.
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Novartis and Astellas aim to use ongoing studies to convince FDA to remove a requirement for a "black box" warning of potential cancer risk in labeling for their topical calcineurin inhibitors