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Elidel, Protopic “Black Box” Could Be Test Of FDA’s Labeling Authority

Executive Summary

FDA's proposal to add a "black box" to labeling of the eczema treatments Elidel and Protopic could be a high-profile test of the agency's ability to change product labeling following recent congressional discussion of the agency's authority

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Mass. Medicaid puts Elidel, Protopic on prior authorization

Massachusetts Medicaid will require prior authorization for Novartis' Elidel (pimecrolimus) and Astellas' Protopic (tacrolimus) effective Aug. 1. Decision was prompted by FDA's March public health advisory on the topical eczema agents, including a request that labeling add a "black box" warning to reflect potential cancer risk (1"The Pink Sheet" March 14, 2005, p. 18). MassHealth says it wanted to ensure that the agents are used as second-line therapy and not in children under two...

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