Elan Prialt Intrathecal Delivery Effectively Limits Use To Experts, FDA Concludes
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Intrathecal administration effectively limits use of Elan's Prialt (ziconotide) to specialists, a de facto restriction that tempered FDA concerns about a drug characterized by what one agency official called "profound toxicity" and "meager" efficacy
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Overly Aggressive Prialt Dose Data Are Not Surrogate Endpoints, FDA Says
Data from failed dosing protocols do not constitute surrogate endpoints, FDA informed Elan in rejecting the company’s bid for accelerated approval of Prialt.