Revision of OTC antihistamine final monograph may be necessary -- FDA's Weintraub.
This article was originally published in The Tan Sheet
Executive Summary
OTC ANTIHISTAMINE FINAL MONOGRAPH WOULD HAVE TO BE REVISED if FDA decides to require clinical studies to support a cold indication for every Category I antihistamine ingredient, FDA Office of Drug Evaluation V Director Michael Weintraub, MD, stated at the Nov. 16 meeting of the Nonprescription Drugs and Pulmonary-Allergy Drugs Advisory Committees in Rockville.