Nexium Superiority Claim To Prilosec Needs Equal Dose Test – FDA Reviewer
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Superiority of AstraZeneca's Nexium (esomeprazole) over parent compound Prilosec (omeprazole) would need to be established by studies assessing equal doses of the proton pump inhibitors, FDA medical reviewer Hugo Gallo-Torres, MD/PhD, said in his review of the Nexium NDA.