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# Ortho NDA Resubmission for Psoriasis Lotion
- URL: https://www.fdaweb.com/ortho-nda-resubmission-for-psoriasis-lotion/
- Published: 2018-08-29T12:00:00.000Z
- Updated: 2026-09-15T00:28:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142230

FDA has accepted for review an Ortho Dermatologics NDA resubmission for Duobrii (halobetasol propionate and tazarotene) lotion, indicated for treating plaque psoriasis. In June, FDA issued a complete response letter, rejecting the NDA over questions regarding pharmacokinetic data, according to the company. The agency has accepted the filing as Class 2 resubmission, with a user fee review action target of 2/15/19\. “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,” Ortho says.