OTC clemastine data for common cold can be generalized to children -- FDA advisory cmte..
This article was originally published in The Tan Sheet
Executive Summary
OTC CLEMASTINE DATA CAN BE GENERALIZED TO PEDIATRIC POPULATIONS for treatment of the common cold, FDA's Nonprescription Drugs and Pulmonary-Allergy Drugs Advisory Committees agreed at a Nov. 16 joint meeting in Rockville, MD. The committees voted 12-3 that the common cold is sufficiently similar in the adult and pediatric populations to allow the results of Sandoz' two randomized, double-blind, placebo-controlled trials to be extrapolated to children six to 12.