Advanced Polymer Systems
This article was originally published in The Rose Sheet
Executive Summary
Firm plans to change labeling for its Exact benzoyl peroxide acne medication vanishing cream and acne cleanser after receiving an April 13 warning letter from FDA. The label modifications, which are awaiting an agency response, eliminate the claim that Exact contains "microscopic sponges that time-release benzoyl peroxide" because FDA pointed out that the topical acne drug monograph does not provide for the "time release or continuous release" of anti-acne products. APS said it also plans to change other aspects of the labeling to be in compliance with the monograph