Ortho Retin-A Micro for acne use clears FDA Feb. 7; labeling features low irritation data.
This article was originally published in The Rose Sheet
Executive Summary
ORTHO RETIN-A MICRO POSITIONED AS LESS IRRITATING ALTERNATIVE to the Johnson & Johnson division's flagship acne product Retin-A (tretinoin cream .1%). The new formulation of the anti-acne agent tretinoin had a 3% rate of skin irritation in clinical trials, according to product labeling. "No more than 3% of patients had scores indicative of a severe irritation rating; although 6% (14/224) of patients treated with Retin-A Micro (tretinoin gel microsphere .1%) discontinued treatment due to irritation," labeling states.