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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.

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