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FDA Crushes Endo’s Hopes, Allows Original Opana Generics To Remain On Market

This article was originally published in The Pink Sheet Daily

Executive Summary

The agency finds reformulated Opana insufficient to deter abuse through most routes of administration and decides the original version was not removed from the market for efficacy and safety reasons; Endo had weaker in vitro and post-market data than Purdue did in its successful Oxycontin petition.

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