Nasacort AQ Switch Gets NDAC Nod Despite Pediatric Use Concerns
This article was originally published in The Tan Sheet
Executive Summary
FDA’s Nonprescription Drugs Advisory Committee voted 10 to 6, with two abstentions, in favor of Sanofi’s application to switch the intranasal corticosteroid Nasacort AQ. Chief among the panel’s concerns is the risk of growth suppression in young children who could use the OTC drug without physician monitoring.