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.
You may also be interested in...
Actavis Must Withdraw Opana ER Generic Four Years After Launch
Court finds Actavis infringed two Endo patents, judge to decide whether to award damages. Actavis' non-crush-resistant generic has impeded sales of Endo's newer crush-resistant version.
Endo Seeks To Block Generics Of Opana ER That Are Not Crush-Resistant
Endo citizen petition asks FDA to determine that the company’s old formulation was withdrawn for safety reasons and to decline approval of ANDAs of that formulation; Purdue Pharma files third OxyContin citizen petition.
Long-Acting Opioid REMS Tally: FDA Lists 12 Brand, 23 Generic
Nineteen companies will implement individual Risk Evaluation and Mitigation Strategies for long-acting/extended-release opioid products that are subject to the class-wide REMS unveiled by FDA July 9.