Schering-Plough Noxafil "approvable"
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Schering-Plough plans to respond to FDA's request for additional data "as soon as possible" following the agency's June 10 "approvable" letter for the oral triazole antifungal Noxafil (posaconazole). Noxafil's user fee date for treatment of refractory invasive fungal infections fell in March, but Schering previously said the agency extended the review timeframe for an undisclosed length of time. The firm had been projecting a first-half 2005 decision...