FDA Accepts Arcutis Biotherapeutics ’ New Drug Application for Roflumilast Cream for Adults and Adolescents with Plaque Psoriasis

FDA has set a target action date of July 29, 2022 NDA supported by positive efficacy data from the pivotal Phase 3 DERMIS 1 and DERMIS 2 clinical studies, as well as results from the long-term safety study If approved, roflumilast cream would...
Source: Drugs.com - New Drug Applications - Category: Drugs & Pharmacology Source Type: news