FDA approves Duobrii lotion to treat psoriasis
Bausch Health Companies Inc. and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses, announced that the 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. 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. Duobrii is expected to be available in June 2019.
When used separately to treat plaque psoriasis, the duration of use of halobetasol propionate is limited by FDA labeling constraints and the use of tazarotene can be limited due to tolerability concerns. By combining halobetasol propionate and tazarotene in an advanced, patented once-daily moisturizing lotion, the Duobrii formulation ensures uniform distribution, allowing for simultaneous contact with the skin surface.
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