Schering-Plough submits Noxafil NDA
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Schering-Plough's triazole antifungal Noxafil (posaconazole) has a user fee date of March 2005 under a standard review clock, the company announces July 13. The May NDA covers treatment of invasive fungal infections refractory to or intolerant of existing therapies. Phase III results presented at the American Society of Hematology meeting in December 2003 showed an overall success rate of 42% for Noxafil vs. 26% for standard therapy (1Pharmaceutical Approvals Monthly Dec. 1, 2003, In Brief)...