Editor’s note: This is the final article in a series from the Food and Drug Administration (FDA) highlighting some of the 500 products that have received new pediatric labeling information since 1998.
Over the past 15 years, 51 pulmonary, allergy and rheumatology products have been studied in the pediatric population. The range of indications includes the treatment of asthma, bronchospasm, allergic rhinitis (seasonal and perennial), congestion, chronic idiopathic urticaria, polyarticular and systemic juvenile idiopathic arthritis.
As a result of these studies, all 51 products carry an indication for at least a portion of the pediatric population. Of these, 26 are locally acting, orally or nasally inhaled products indicated to treat asthma or allergic rhinitis. This article focuses on how pediatric safety and efficacy are evaluated for these locally acting products.
For asthma and allergic rhinitis products, 12- to 18-year-old patients generally are included in the adult safety/efficacy trials, so initial...