Brompheniramine efficacy against cold symptoms shown in study, Whitehall tells FDA.
This article was originally published in The Tan Sheet
Executive Summary
BROMPHENIRAMINE STUDY "STRONGLY SUPPORTS" EFFICACY AGAINST COLDS, WHITEHALL told FDA in a May 7 submission on the antihistamine ingredient. The study, involving 225 subjects, was conducted by Jack Gwaltney, MD, University of Virginia, from November 1995 through August 1996. Results were submitted by Whitehall-Robins along with other data in response to the 1995 conclusion by a joint FDA advisory committee that there are insufficient data to establish the effectiveness of brompheniramine for the cold indication.