PREMARIN DHES COMPONENT "EXTREMELY UNLIKELY" TO ADD TO EFFICACY, SAYS UMASS' LONGCOPE IN COMMENTS FOR BARR; FDA MEETING WILL HEAR GENERIC COMMENTS
Executive Summary
Wyeth-Ayerst's Premarin constituent delta-8,9 dehydroestrone sulfate (DHES) has a small likelihood of contributing any significant activity to the conjugated estrogens product, asserts Barr Labs consultant Christopher Longcope, MD, University of Massachusetts Medical School, in recent comments to FDA. Longcope's comments are part of a filing by Barr in opposition to Wyeth's petition to stay approvals of generic conjugated estrogens products that do not contain DHES.