title: An overview of the pediatric medications for the symptomatic treatment of allergic rhinitis, cough, and cold.
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.
authors.affiliation: Division of Clinical Pharmacology II, Office of Clinical Pharmacology, U.S. Food and Drug Administration, Silver Spring, Maryland, 20993.
authors.forename: Ying
authors.initials: Y
authors.lastname: Fan
authors.forename: Ping
authors.initials: P
authors.lastname: Ji
authors.forename: Andrea
authors.initials: A
authors.lastname: Leonard-Segal
authors.forename: Chandrahas G
authors.initials: CG
authors.lastname: Sahajwalla
mesh_terms: D000305:Adrenal Cortex Hormones / Q000494:pharmacology / Q000627:therapeutic use*; D000818:Animals; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000494:pharmacology / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D003371:Cough / Q000188:drug therapy*; D055808:Drug Discovery / Q000379:methods; D006633:Histamine Antagonists / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D007052:Ibuprofen / Q000494:pharmacology / Q000627:therapeutic use*; D020024:Leukotriene Antagonists / Q000494:pharmacology / Q000627:therapeutic use*; D065631:Rhinitis, Allergic; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy*
chemical_list: D000305:Adrenal Cortex Hormones; D000894:Anti-Inflammatory Agents, Non-Steroidal; D006633:Histamine Antagonists; D020024:Leukotriene Antagonists; D007052:Ibuprofen
keywords: Allergic rhinitis; Clinical Pharmacokinetics; Clinical pharmacology; Cough and cold; Pediatrics; Pharmacodynamics; Pharmacokinetics; Population Pharmacokinetics