Schering AG/Epix Imaging Agent Requires Additional Clinical Studies – FDA
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Schering AG/Epix MS-325 imaging agent requires additional clinical studies, FDA says in “approvable” letter. Outstanding questions relate to the non-contrast comparator scanning methods used in Phase III trials and statistical treatment of uninterpretable baseline scans
You may also be interested in...
Pfizer, Allergan And Schering NMEs Receive Second “Approvable” Letters
Pfizer’s anidulafungin received a second “approvable” letter Nov. 25 for treatment of esophageal candidiasis, FDA said.
Pfizer, Allergan And Schering NMEs Receive Second “Approvable” Letters
Pfizer’s anidulafungin received a second “approvable” letter Nov. 25 for treatment of esophageal candidiasis, FDA said.
Epix MS-325 User Fee Goal Is Oct. 15; Broad Vascular Imaging Claim Sought
FDA’s decision to assign Epix’s vascular imaging agent MS-325 a standard review sets the user fee goal for the NDA at Oct. 15.