International Circuit
Bausch Health Provides Update for DUOBRII Filing
Bausch Health Companies Inc. and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology healthcare 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 percent/0.045 percent, 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. – Medical Buyer Bureau