Ortho Dermatologics Resubmits NDA for Duobrii

Ortho Dermatologics has resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Duobrii (halobetasol propionate and tazarotene) (IDP-118) lotion in the treatment of plaque psoriasis.

"After meeting with the FDA and understanding the additional pharmacokinetic data required for DUOBRII, we have resubmitted the NDA ahead of schedule," said Joseph C. Papa, chairman and CEO, Bausch Health. "We continue to have confidence in an approval of Duobrii and hope to bring forward this important new treatment option for those who suffer from plaque psoriasis as quickly as possible."

If approved, Duobrii will be the first and only topical lotion that contains a unique combination of halobetasol propionate and tazarotene in one formulation for the treatment of plaque psoriasis in adult patients, allowing for a potentially expanded duration of use.

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