FDA Accepts Ortho Derm's Resubmission of NDA for Duobrii Lotion for Plaque Psoriasis

Wednesday, August 29, 2018 | FDA Approval/Clearance , Psoriasis , Ortho Dermatologics

The FDA has accepted Ortho Dermatologics' resubmitted New Drug Application (NDA) for Duobrii (halobetasol propionate and tazarotene) (IDP-118) Lotion for the topical treatment of plaque psoriasis. The FDA accepted the application as a Class 2 resubmission, with a PDUFA action date of Feb. 15, 2019.
“We are confident in our NDA resubmission for Duobrii and unwavering in our commitment to bring this new treatment option to patients,” says Bill Humphries, president, Ortho Dermatologics, in a news release. “We have worked closely with the FDA to answer their questions regarding pharmacokinetic data, and we look forward to continued collaboration with the Agency through the remainder of the review process.”
If approved, Duobrii will be the first 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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