Solvay Estratab

Executive Summary

FDA objects to statement that esterified estrogens are a "natural" alternative to Wyeth-Ayerst's Premarin (conjugated estrogens) in brochures, a press kit entitled "A New Option for Preventing Osteoporosis" and a B-roll video. The statement is an implied superiority claim, FDA contends in April 7 letter. In addition, suggestions in Solvay's Estratab video that the .3 mg dose is not associated with a risk of endometrial hyperplasia are lacking in fair balance because women take estrogens chronically for osteoporosis; the risk of hyperplasia "would be expected to increase with the duration of use," FDA says