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FDA Rejects Endo’s Deadline On Opana ER Petition; Impax Product May Become New RLD

This article was originally published in The Pink Sheet Daily

Executive Summary

Endo files suit against FDA seeking preliminary injunction to require FDA to say whether Endo’s withdrawal of non-crush resistant Opana ER was for safety reasons; FDA contends it has until May 10, 2013 to make this decision.

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