First and Only Topical Lotion Combining Halobetasol Propionate and Tazarotene in One Formulation1
Safety was Established in a Long-Term Study of Up to 24 Weeks of Continuous Use and up to 52 Weeks of As-Needed Use2
RALEIGH, N.C., Apr. 25, 2019 – Ortho Dermatologics, one of the largest prescription dermatology health care businesses in the world, today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application for DUOBRII™ (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045%, indicated for the topical treatment of plaque psoriasis in adults.1 DUOBRII is the first and only topical lotion that contains a unique combination of halobetasol propionate and tazarotene in one formulation. In a year-long safety study, patients used DUOBRII Lotion for up to 24 weeks of continuous use and up to 52 weeks of as-needed use.2 DUOBRII is expected to be available in June 2019.
1. DUOBRII™ [prescribing information]. Bridgewater, NJ: Bausch Health US, LLC.
2. Lebwohl, M.G. et al. Long-term safety results from a phase 3 open-label study of a fixed combination halobetasol propionate 0.01% and tazarotene 0.045% lotion in moderate-to-severe plaque psoriasis. Journal of Americal Academy of Dermatology. 2019 Jan;80(1):282-285.