Vasoconstrictor Pupil Dilation Warning Established In Final Rule
This article was originally published in The Tan Sheet
Executive Summary
A pupil dilation warning on both single- and combination-ingredient OTC vasoconstrictor eyedrops will be required by FDA despite previous objections from industry.
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Combo OTC Drug Labeling Deadlines To Be Addressed In Final Monographs
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Vasoconstrictor warning "not appropriate" for single ingredient products -- NDMA.
VASOCONSTRICTOR WARNING "NOT APPROPRIATE" FOR MONOGRAPH OTCs, NDMA maintains in May 26 comments on FDA's Feb. 23 proposed label warning on vasoconstrictors regarding the possibility of pupil dilation. The Nonprescription Drug Manufacturers Association opposes the warning on single ingredient monograph products, arguing the agency proposal is based on adverse drug experiences (ADEs) for three Rx-to-OTC switch products that contain both a vasoconstrictor and pheniramine maleate, an antihistamine. "The market experience with single ingredient ophthalmic vasoconstrictor products does not demonstrate the same pattern of adverse experience reports and does not warrant FDA's current action," NDMA says.