Berlex Laboratories Climara
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
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth