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Mylan Apokyn Review Hampered By "Ubiquitous Use" Of Tigan In Trials

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA's Neuropharm division felt use of the older antiemetic in Parkinson's therapy trials posed "thorny problem" due to lack of chronic experience with Tigan and poorly documented concomitant use. FDA ultimately recommends concomitant antiemetic therapy in labeling, as well as a Phase IV study to determine the "actual necessity" of Tigan in combination with Apokyn.

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