Tazarotene/ulobetasol - Ortho Dermatologics

Drug Profile

Tazarotene/ulobetasol - Ortho Dermatologics

Alternative Names: DUOBRII; Halobetasol propionate/tazarotene; IDP-118; Tazarotene/halobetasol propionate; Ulobetasol/tazarotene

Latest Information Update: 04 Sep 2018

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At a glance

  • Originator Dow Pharmaceutical Sciences
  • Developer Ortho Dermatologics
  • Class Antipsoriatics; Corticosteroids; Cyclopentanes; Keratolytics; Nicotinic-acids; Phenanthrenes; Pyridines; Retinoids; Small molecules
  • Mechanism of Action Retinoid X receptor agonists; Steroid receptor agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity No

Highest Development Phases

  • Preregistration Plaque psoriasis

Most Recent Events

  • 29 Aug 2018 FDA reassigns PDUFA action date of 15/02/2019 for tazarotene/ulobetasol for Plaque psoriasis
  • 29 Aug 2018 US FDA accepts resubmission of NDA for tazarotene/ulobetasol for Plaque psoriasis for review
  • 15 Aug 2018 Ortho Dermatologics resubmits NDA for topical tazarotene/ulobetasol for Plaque psoriasis to the US FDA
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