Ortho Dermatologics announced that the Food and Drug Administration (FDA) has accepted the resubmitted New Drug Application (NDA) for Duobrii (halobetasol propionate and tazarotene) Lotion for the topical treatment of plaque psoriasis.
Duobrii Lotion is unique in that it combines halobetasol propionate, a topical steroid, and tazarotene, a retinoid. If approved, it would be the first topical lotion with this combination for the treatment of adults with plaque psoriasis. Its long-term safety was evaluated in a phase 3, multicenter, open-label study of 555 adults with moderate to severe plaque psoriasis. The primary outcome measure was the percent of subjects who experienced a local skin reaction (grade 3 on the IGA scale at any point in the study).
In June 2018, the FDA had issued a Complete Response Letter for Duobrii Lotion with questions regarding pharmacokinetic data.
The FDA has set a target Prescription Drug User Fee Act (PDUFA) date of February 15, 2019.
For more information visit Ortho-Dermatologics.com.