15 February 2019 - Bausch Health announced that the U.S. FDA will be unable to meet today's Prescription Drug User Fee Act date for the new drug application for Duobrii (halobetasol propionate and tazarotene) lotion, 0.01%/0.045%, for the topical treatment of plaque psoriasis in adults.
The FDA is close to finalising its review, and we expect a decision from the FDA shortly.