Posted by Michael Wonder on 30 Aug 2018
FDA accepts resubmission of new drug application for Duobrii (halobetasol propionate and tazarotene) lotion
29 August 2018 - Ortho Dermatologics today announced that the U.S. FDA has accepted the resubmitted new drug application 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 15 February 2019.
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.
