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