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.