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Duobrii FDA Approval History

Last updated by Judith Stewart, BPharm on April 26, 2019.

FDA Approved: Yes (First approved April 25, 2019)
Brand name: Duobrii
Generic name: halobetasol propionate and tazarotene
Dosage form: Lotion
Company: Bausch Health Companies Inc.
Treatment for: Plaque Psoriasis

Duobrii (halobetasol propionate and tazarotene) is a corticosteroid and retinoid combination indicated for the topical treatment of plaque psoriasis.

  • Duobrii Lotion contains halobetasol propionate 0.01% and tazarotene 0.045%. It is the the first FDA approved combination of the two drugs - both widely used individually as topical treatments for psoriasis, with established safety profiles.
  • Halobetasol propionate is available as a generic in a topical cream 0.05% formulation, and tazarotene is available as a generic in a topical cream 0.1% formulation.
  • According to the results of a phase 2 study, the halobetasol propionate/tazarotene combination lotion was "consistently" more effective than its individual agents and vehicle in achieving treatment success.
  • Duobrii Lotion is applied as a thin layer to the affected areas once daily.
  • Tazarotene may cause birth defects if used during pregnancy. Females of reproductive potential should obtain a negative pregnancy test within two weeks prior to using Duobrii and must use an effective method of contraception during treatment to avoid pregnancy.
  • Duobrii Lotion may cause photosensitivity reactions and increase the risk for sunburn. Patients should avoid natural and artificial sunlight, including sunlamps and tanning beds, and use sunscreen and wear a hat and protective clothing when outdoors to prevent sunburn during treatment with Duobrii.
  • The most common adverse events reported in clinical trials include redness, itching, swelling, burning, stinging, application site pain, inflamed hair follicles (folliculitis), thinning of the skin (atrophy), peeling and rash.

Development timeline for Duobrii

Apr 25, 2019Approval FDA Approves Duobrii (halobetasol propionate and tazarotene) Lotion 0.01%/0.045% for Plaque Psoriasis In Adults
Aug 15, 2018Ortho Dermatologics Resubmits U.S. New Drug Application for Duobrii (halobetasol propionate and tazarotene) Lotion
Jun 18, 2018FDA Issues Complete Response Letter for Duobrii (halobetasol propionate and tazarotene) Lotion
Nov  2, 2017Ortho Dermatologics Announces U.S. FDA Filing Acceptance For IDP-118, Novel Plaque Psoriasis Treatment

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.