Novartis' Elidel, Fujisawa's Protopic To Add "Black Box" On Cancer Risk
This article was originally published in The Pink Sheet Daily
Executive Summary
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.
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Elidel Labeling (Clarification)
An Oct. 18 1story in "The Pink Sheet" DAILY on declining sales for Novartis' eczema treatment Elidel (pimecrolimus) did not describe with sufficient clarity the status of discussions between the firm and FDA on labeling changes
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