OTC clemastine data shows significant improvement in cold symptoms versus placebo.
This article was originally published in The Tan Sheet
Executive Summary
OTC CLEMASTINE DATA SHOWS "SIGNIFICANT" IMPROVEMENT IN COLD SYMPTOMS compared to placebo, Sandoz Clinical Research & Medical Affairs Associate Director Lori Beth Cirangle, MD, reported at a Nov. 16 meeting of FDA's Nonprescription Drugs and Pulmonary-Allergy Drugs Advisory Committees. The session was held to determine whether pre-NDA data submitted by Sandoz that included two clinical studies support a common cold indication for 1.34 mg clemastine fumarate .