OTC ophthalmic demulcents
This article was originally published in The Tan Sheet
Executive Summary
FDA denies March 1989 petition from Alcon Labs requesting that the agency amend the OTC ophthalmic demulcents final monograph to include Dextran 75.1% when used with another polymeric demulcent drug. "Adequate physico-chemical information" must be submitted and approved before Dextran 75 can be included in combination with another ingredient, FDA said in a recent letter, and "at least two adequate and well-controlled studies" are needed to include Dextran 75 as the sole demulcent ingredient in OTC ophthalmic products