Ortho Dermatologics, one of the largest prescription dermatology health care businesses in the world and a division of Bausch Health Companies Inc. (NYSE/TSX: BHC), today announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmitted New Drug Application (NDA) for DUOBRIITM1 (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 February 15, 2019.
“We are confident in our NDA resubmission for DUOBRII and unwavering in our commitment to bring this new treatment option to patients,” said Bill Humphries, president, Ortho Dermatologics. “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 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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