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
You may also be interested in...
Elidel, Protopic Get Boxed Warnings On Cancer, But Not At Top Of Labeling
Boxed warnings about potential cancer risks will appear in the warning sections for Novartis' Elidel (pimecrolimus) and Astellas' Protopic (tacrolimus)
Elidel, Protopic Get Boxed Warnings On Cancer, But Not At Top Of Labeling
Boxed warnings about potential cancer risks will appear in the warning sections for Novartis' Elidel (pimecrolimus) and Astellas' Protopic (tacrolimus)
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...