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Bryhali Approval History

Reviewed by J.Stewart BPharm. Last updated on Nov 13, 2018.

FDA Approved: Yes (First approved November 6, 2018)
Brand name: Bryhali
Generic name: halobetasol propionate
Dosage form: Lotion
Previous Name: Jemdel
Company: Ortho Dermatologics
Treatment for: Plaque Psoriasis

Bryhali (halobetasol propionate) is a high-potency topical corticosteroid formulation for the treatment of plaque psoriasis in adults.

DOSAGE AND ADMINISTRATION

  • Apply a thin layer of Bryhali Lotion to the affected areas once daily.
  • Discontinue treatment with Bryhali Lotion once the psoriasis is controlled. The treatment period should should not exceed 8 weeks.
  • Avoid bandaging, wrapping or otherwise occluding the treatment area(s) unless directed by a physician.
  • Avoid use on the face, groin, or axillae.
  • Not for oral, ophthalmic, or intravaginal use.

WARNINGS AND PRECAUTIONS

  • Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression was observed and may occur with the potential for glucocorticosteroid insufficiency during or after treatment.
  • Systemic effects of topical corticosteroids may also include Cushing’s syndrome, hyperglycemia, and glucosuria.
  • Systemic absorption may require evaluation for HPA axis suppression.
  • Use of potent corticosteroids on large areas, for prolonged durations, under occlusive dressings, or on an altered skin barrier may increase systemic exposure.
  • Children may be more susceptible to systemic toxicity when treated with topical corticosteroids.
  • Breastfeeding women should not apply Bryhali Lotion directly to the nipple and areola to avoid directly exposing the infant.
  • Local adverse reactions may include atrophy, striae, telangiectasias, hypopigmentation, and allergic contact dermatitis. Some local adverse reactions may be irreversible.
  • Use of topical corticosteroids may increase the risk of posterior subcapsular cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist for evaluation.

ADVERSE REACTIONS

  • The most common adverse reactions (≥1%) were upper respiratory tract infection, application site dermatitis and hyperglycemia.

Development History and FDA Approval Process for Bryhali

DateArticle
Nov  7, 2018Approval Bausch Health Announces U.S. Launch of Bryhali (halobetasol propionate) Lotion, 0.01%, for Plaque Psoriasis In Adults
Oct  9, 2018Bausch Health's Bryhali (halobetasol propionate) Lotion, 0.01%, Receives Tentative FDA Approval For Plaque Psoriasis In Adults
Feb 14, 2018Ortho Dermatologics Announces U.S. FDA Filing Acceptance for Jemdel Plaque Psoriasis Treatment

Further information

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

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