Acetaminophen Panel To Mull Expanded Dosing, Standard Solid Concentration
This article was originally published in The Tan Sheet
Executive Summary
FDA is asking a joint advisory panel to consider whether it should restrict firms to one standard acetaminophen concentration for all solid oral dosage single-ingredient pediatric products, among other measures to reduce dosing errors.
You may also be interested in...
Pediatric Acetaminophen Panel Debates Execution Of Dosing Changes
Pediatric OTC acetaminophen product labels should include directions for children under 2 years and as young as 6 months and instructions for dosing by weight, a panel of advisors told FDA.
OTC Industry Standardizes Pediatric Liquid Acetaminophen Concentration
Over-the-counter drug firms will make single-ingredient liquid acetaminophen pediatric products only in one standard concentration to help prevent dosing errors, their trade association said May 4.
FDA Advisory Panel To Evaluate Acetaminophen Pediatric Dosing
FDA's pediatric and nonprescription drugs advisory committees will consider whether the agency should add dosing information for children under 2 years to labels for OTC products containing acetaminophen at a joint meeting May 17-18.