halobetasol propionate

FDA Drug Profile — Bryhali, LEXETTE, Halobetasol Propionate

Drug Details

Generic Name
halobetasol propionate
Brand Names
Bryhali, LEXETTE, Halobetasol Propionate
Application Number
NDA209355
Sponsor
Bausch Health US, LLC
NDC Codes
4
Dosage Forms
LOTION, POWDER, AEROSOL, FOAM, CREAM
Routes
TOPICAL
Active Ingredients
HALOBETASOL PROPIONATE

Indications and Usage

INDICATIONS AND USAGE Halobetasol Propionate Ointment 0.05% is a super-high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond two consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in children under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.