Par/Advancis Pulsatile Amoxicillin Filing Plans On Hold After Phase III Failure
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
A potential NDA submission for Advancis' Pulsys pulsatile amoxicillin formulation will be delayed at least until late 2006 following failure of a Phase III trial to show statistical non-inferiority to penicillin