In Brief: Renova
This article was originally published in The Tan Sheet
Executive Summary
Renova: Johnson & Johnson's Ortho subsidiary to launch Rx skin treatment in February after Dec. 29 approval by FDA. Renova (tretinoin emollient cream .05%) is indicated as an "adjunctive agent for use in the mitigation of fine wrinkles, mottled hyperpigmentation and tactile roughness of facial skin." In clinical trials, most of the skin improvement occurred during the first 24 weeks. "The safety and effectiveness of using Renova daily for greater than 48 weeks have not been established," labeling notes. Renova is contraindicated in pregnant women or those at high risk for pregnancy due to a lack of safety data in those subjects...