Ortho's Renova

Executive Summary

Tradename for tretinoin .05% emollient cream for photoaging is Renova, changed by Ortho from Renuva at the behest of FDA. FDA's Dermatologic Drugs Advisory Committee advised Ortho to change the name because Renuva sounded too close to an indication of skin renewal. The committee recommendation followed a May 21, 1990 session which explored some of the issues that have surfaced with respect to the agency review ("The Pink Sheet" May 28, T&G-8). Ortho submitted the NDA for the product in July 1990.