Bausch Health Companies Inc. (NYSE/TSX: BHC) and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses, announced that the U.S. Food and Drug Administration (FDA) will be unable to meet today’s Prescription Drug User Fee Act (PDUFA) 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 finalizing its review, and we expect a decision from the FDA shortly.
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