A Phase 3, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of IDP-118 in the Treatment of Plaque Psoriasis
Phase of Trial: Phase III
Latest Information Update: 02 Nov 2017
At a glance
- Drugs Tazarotene/ulobetasol (Primary)
- Indications Plaque psoriasis
- Focus Registrational; Therapeutic Use
- Sponsors Valeant Pharmaceuticals International
- 02 Nov 2017 According to an Ortho Dermatologics media release, U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for IDP-118 (halobetasol propionate and tazarotene) lotion, an investigational topical treatment for plaque psoriasis.The PDUFA action date is June 18, 2018.
- 05 Sep 2017 Primary endpoint has been met. (The percent of subjects with treatment success), as reported by an Ortho Dermatologics Media Release.
- 05 Sep 2017 According to an Ortho Dermatologics media release, based on the data from this and other trial (see profile 257590), the company has submitted a New Drug Application (NDA) to the U.S. FDA for IDP-118 (halobetasol propionate and tazarotene) lotion for the treatment of plaque psoriasis.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History