FDA warns on unsubstantiated claims for Ista's Xibrom and Sirion's Durezol
This article was originally published in Scrip
Executive Summary
A professional sales aid in support of Ista Pharmaceuticals' NSAID eye drop Xibrom (bromfenac ophthalmic solution) makes unsubstantiated superiority claims, broadens the indication of Xibrom, overstates its efficacy, omits and minimises important risk information, and makes misleading patient preference claims, the US FDA's division of drug marketing, advertising and communications (DDMAC) said in a warning letter to the company. It has requested a corrective messaging plan for those who received the information.