FDA final pediatric research list retains same 23 OTCs as March draft.
This article was originally published in The Tan Sheet
Executive Summary
MONOGRAPHed OTCs ON FDA PEDIATRIC LIST NOT ELIGIBLE FOR EXCLUSIVITY, NDMA says, and asks FDA to clarify this in its final list of adult drugs for which additional data could provide health benefits for children. In recent comments on FDA's March draft list, the Nonprescription Drug Manufacturers Association notes that OTC monograph ingredients are not eligible for the six months of regulatory or patent exclusivity offered by FDA for additional research, and suggests the agency, "for clarity...should preface the final list with an explanation that the list only applies to preapproval drugs and those subject to approved applications but not to those regulated under OTC monographs."