Berlex Laboratories Climara
Executive Summary
There are no clinically significant differences among the various transdermal patches for weekly estrogen delivery, FDA tells company in July 9 letter. Climara, Warner-Lambert's Fempatch, Proctor & Gamble's Alora, and Novartis' Vivelle "are all considered to have the same, essentially superimposable delivery," FDA declares. Therefore, the agency objects to a detail aid featuring the headline, "The Climara Advantage," and comparative information on estrogen delivery because it implies superiority