Bryhali

Product Type: HUMAN PRESCRIPTION DRUG

Route: TOPICAL

Dosage Form:

NDC: 0187-0002

Application: NDA209355

Effective: 20200601

1 INDICATIONS AND USAGE BRYHALI ® (halobetasol propionate) lotion, 0.01% is indicated for the topical treatment of plaque psoriasis in adults. BRYHALI lotion is a corticosteroid indicated for the topical treatment of plaque psoriasis in adults. ( 1 )

2 DOSAGE AND ADMINISTRATION Apply a thin layer of BRYHALI Lotion to affected areas once daily. Rub in gently. Wash hands after each application, unless BRYHALI Lotion is for treatment of the hands. BRYHALI Lotion treatment beyond 8 weeks is not recommended, and the total dosage should not exceed approximately 50 g per week. Discontinue treatment if control is achieved before 8 weeks. Do not use with occlusive dressings unless directed by a physician. BRYHALI Lotion should not be used on the face, groin, or in the axillae. BRYHALI Lotion is not for oral, ophthalmic, or intravaginal use. • Apply a thin layer of BRYHALI Lotion to the affected areas once daily. ( 2 ) • Treatment beyond 8 weeks is not recommended. Discontinue treatment if control is achieved before 8 weeks. ( 2 ) • Do not use with occlusive dressings unless directed by a physician. ( 2 ) • Avoid use on the face, groin, or axillae. ( 2 ) • Not for oral, ophthalmic, or intravaginal use. ( 2 )

4 CONTRAINDICATIONS None. None ( 4 ).

Not available.

6 ADVERSE REACTIONS • The most common adverse reactions (≥1%) were upper respiratory tract infection, application site dermatitis and hyperglycemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In randomized, double-blind, multicenter, vehicle-controlled clinical trials, 426 adults with plaque psoriasis were treated with BRYHALI Lotion and had post-baseline safety data. Subjects applied BRYHALI Lotion once daily for up to 8 weeks. Table 1 presents adverse reactions that occurred in at least 1% of subjects treated with BRYHALI Lotion and more frequently than in vehicle-treated subjects. Table 1: Adverse Reactions Occurring in ≥1% of the Subjects Treated with BRYHALI Lotion through Week 8 BRYHALI Lotion (N=284) Vehicle Lotion (N=142) Adverse Reaction % % Upper Respiratory Tract Infection 2% 1% Application Site Dermatitis 1% 0 Hyperglycemia 1% 0