Psoriasis lotion seeks FDA approval

September 12, 2018

Ortho Dermatologics announced in August that it resubmitted a new drug application to the FDA for DUOBRIITM1, a lotion for the treatment of plaque psoriasis.

Ortho Dermatologics announced in August that it resubmitted a new drug application to the Food and Drug Administration (FDA) for DUOBRIITM1 (halobetasol propionate and tazarotene) (IDP-118), a lotion for 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 only topical lotion based on a combination of halobetasol propionate and tazarotene for plaque psoriasis in adults.

download issueDownload Issue : Dermatology Times, September 2018 (Vol. 39, No. 9)