Novartis, Astellas Intend To Disprove Eczema Treatments’ Cancer Risk
This article was originally published in The Pink Sheet Daily
Executive Summary
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
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FDA Approves Boxed Warning On Cancer Risk For Elidel And Protopic
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.
Novartis' Elidel, Fujisawa's Protopic To Add "Black Box" On Cancer Risk
Novartis expects labeling negotiations will begin within the next few weeks and says a "black box" is unjustified. A medication guide will also be required for the eczema treatments, FDA says.