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Endo’s Aveed and the State of REMS After Five Years

This article was originally published in RPM Report

Executive Summary

The REMS era is five years old – almost as old as the original NDA filing for Endo’s long-acting testosterone injection Aveed. A recent FDA advisory committee review of that application (now on its third cycle) captures many of the current themes in REMS policy.

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REMS Can’t Help Endo’s Aveed – Won’t Address Unpredictable Safety Events, FDA Advisors Say

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