FDA Advisory Panel To Evaluate Acetaminophen Pediatric Dosing
This article was originally published in The Pink Sheet Daily
FDA expects the meeting to focus on single ingredient products, especially for children younger than 2, and to consider adding a weight-based dosing regimen to the existing age-based dosing for children 2-12.
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OTC PEDIATRIC ANALGESIC/ANTIPYRETIC LABELING FOR CHILDREN UNDER TWO YEARS recommended by FDA's Nonprescription Drugs Advisory Committee at its Sept. 18 meeting in Gaithersburg, Md. Members of the Arthritis Advisory Committee also attended. The committee met to discuss labeling directions for two product formulations: suspension liquid, which is labeled for use by children ages two to 11, and concentrated infant drops, labeled for use by children two and three years old. The meeting marked the second consideration by the advisory committee of issues relating to the proper dosing of pediatric medications. The first occurred in early 1995 ("The Tan Sheet" Jan. 16, 1995, p. 10).
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