FDA accepts Bausch Health's resubmission for Duobrii in plaque psoriasis

Bausch Health's Ortho Dermatologics unit announced Wednesday that the FDA accepted a resubmitted filing seeking approval of Duobrii (halobetasol propionate/tazarotene) lotion for the topical treatment of plaque psoriasis. The company noted that the application has been assigned a target review date of February 15 next year.

In June, the FDA issued a complete response letter regarding a filing for Duobrii, with the agency asking for more information on pharmacokinetic data. Bill Humphries, president of Ortho Dermatologics, remarked "we have worked closely with the FDA to answer their questions regarding pharmacokinetic data, and we look forward to continued collaboration…through the remainder of the review process."

Late-stage study results reported last year showed that Duobrii, also known as IDP-118, was linked to a significantly higher rate of treatment success, defined in part as the achievement of a "clear" to "almost clear" skin score, versus vehicle in adults with moderate-to-severe psoriasis who received eight weeks of treatment followed by four weeks of follow-up.

Earlier this year, CEO Joseph Papa identified Duobrii as one of seven developmental products with the potential to generate more than $1 billion in revenue.

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