FDA OTC ocular allergy indication guidelines requested by Alcon representative.
This article was originally published in The Tan Sheet
Executive Summary
FDA OTC OCULAR ALLERGY INDICATION GUIDELINES REQUESTED by Harvard Medical School clinical associate professor for ophthalmology Mark Abelson, MD, at the Dec. 9 meeting of the FDA Ophthalmics Subcommittee. Abelson spoke on behalf of Alcon Labs, which markets Naphcon-A OTC eye drops. Abelson's presentation addressed the current situation that some OTC oral antihistamines and ocular vasoconstrictors carry the ocular allergy claim and other OTC antihistamine vasoconstrictor products, like Naphcon-A, do not.