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FDA postpones PDUFA decision for Duobrii a proposed treatment for psoriasis.- Ortho Dermatologics

Read time: 1 mins
Last updated:17th Feb 2019
Published:17th Feb 2019
Source: Pharmawand

Bausch Health Companies Inc.and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses, announced that the FDA will be unable to meet the 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 a decision is expected shortly.

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