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An Overview of the Pediatric Medications for the Symptomatic Treatment of Allergic Rhinitis, Cough, and Cold

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  • Opinions expressed in this article are those of the authors’ and do not reflect the views or policies of the U.S. Food and Drug Administration. Please contact the regulatory agency where the submission is being filed to find out about the current guidance and regulatory standards.

Abstract

Upper respiratory infections and allergic rhinitis are common diseases in children. In recent years, U.S. Food and Drug Administration has been promoting pediatric drug development with marketing exclusivity incentives and requirements. The assessment of clinical pharmacology, efficacy, and safety data has facilitated pediatric drug development and provided appropriate labeling for pediatric use. Regulatory decision making involves multiple evaluation processes, including drug exposure comparison between adult and pediatric population, formulation bridging, dose selection, and evaluation of efficacy and safety in pediatric patients. This article reviews the pediatric drugs indicated for cough, cold, and allergic rhinitis, focusing on the utility of clinical pharmacology, safety, and efficacy data in determining the pediatric dosing regimen and the approaches taken for regulatory decision making. © 2013 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 102:4213–4229, 2013

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