Endo Sees Regulatory Setting For Opana ER As "A Moving Target"
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
The “complete response” letter for the crush-resistant formulation of Endo Pharmaceuticals’ chronic pain drug Opana ER (oxymorphone) is not surprising, given that FDA has yet to settle on a risk management approach for extended-release opioids.
You may also be interested in...
FDA Standardizes REMS Documents For Certain Fentanyl Products
ProStrakan's Abstral is first use of the REMS templates; the agency expects sponsors of similar immediate-release transmucosal products to follow suit and share a REMS implementation system.
The REMS Filibuster: FDA Wants Ability To End Post-Approval Talks, Make Final Decision
FDA wants a bigger stick for product-specific Risk Evaluation and Mitigation Strategy negotiations, if for no other reason than to end the talks and make the final decision.
Endo To Gain Full Control Over Leading Growth Product In Penwest Purchase
Sale announced concurrently with filing of NDA for new crush-proof formulation of the opioid Opana ER.