Halobetasol propionate

Product Type: HUMAN PRESCRIPTION DRUG

Route: TOPICAL

Dosage Form:

NDC: 68308-769

Application: ANDA215266

Effective: 20231130

1 INDICATIONS AND USAGE Halobetasol Propionate Topical Foam is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older. Halobetasol Propionate Topical Foam is a corticosteroid indicated for the topical treatment of plaque psoriasis in patients twelve (12) years of age and older. ( 1 )

2 DOSAGE AND ADMINISTRATION Shake can prior to use and turn can completely upside down to dispense. Apply Halobetasol Propionate Topical Foam as a thin uniform film to the affected skin twice daily for up to two weeks. Rub in gently. Wash hands after applying the product. Discontinue therapy when control is achieved. If no improvement is seen within two weeks, reassessment of the diagnosis may be necessary. Treatment beyond two weeks is not recommended and the total dosage should not exceed 50 grams per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis [see Warnings and Precautions (5.1) ] . Do not use with occlusive dressings unless directed by a physician. Avoid use on the face, groin, or axillae. Avoid contact with eyes. Wash hands after each application, unless it is for treatment of the hands. Halobetasol Propionate Topical Foam is for topical use only. Halobetasol Propionate Topical Foam is not for ophthalmic, oral, or intravaginal use. • Shake before use. ( 2 ) • Apply Halobetasol Propionate Topical Foam as a thin uniform film to the affected skin twice daily for up to two weeks. Rub in gently. ( 2 ) • Do not use more than 50 grams per week. ( 2 ) • Discontinue Halobetasol Propionate Topical Foam when control is achieved. ( 2 ) • If no improvement is seen within 2 weeks, reassess diagnosis. ( 2 ) • Treatment beyond 2 consecutive weeks is not recommended. ( 2 ) • Do not use with occlusive dressings unless directed by a physician. ( 2 ) • Avoid use on the face, groin, or axillae. ( 2 ) • Halobetasol Propionate Topical Foam is not for ophthalmic, oral, or intravaginal use. ( 2 )

4 CONTRAINDICATIONS None. None.

Not available.

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label: • Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression and Other Adverse Endocrine Effects [see Warnings and Precautions (5.1) ] • Allergic Contact Dermatitis [see Warnings and Precautions (5.5) ] The most commonly reported adverse reactions (≥1%) are application site pain and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Padagis ® at 1-866-634-9120 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 practice. In randomized, multicenter, vehicle-controlled clinical trials, 351 adults with plaque psoriasis were treated with Halobetasol Propionate Topical Foam twice daily for up to two weeks (up to approximately 50 grams per week). Table 1 presents selected adverse reactions that occurred in at least 1% of subjects. Table 1: Adverse Reactions Occurring in ≥ 1% of Subjects through Week 2 HBP Foam N=351 Vehicle Foam N=353 Adverse Reaction % % Skin atrophy (n=1) and telangiectasia (n=2) were reported with Halobetasol Propionate Topical Foam, but not with vehicle foam. Application site burning/stinging 12% 15% Application site pain 1% <1% Headache 1% <1% 6.2 Postmarketing Experience Because the reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following local adverse reactions have been reported with topical corticosteroids: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria. They may occur more frequently with the use of occlusive dressings and higher potency corticosteroids, such as halobetasol propionate.