Taclonex ointment (Warner Chilcott/LEO Pharma), a combination of the vitamin D3 analog calcipotriene 0.005% (Dovonex) and the high-potency corticosteroid betamethasone dipropionate 0.064%, was recently approved by the FDA for treatment of psoriasis vulgaris in patients ≥ 18 years old.

The FDA has approved Enstilar (Leo), an aerosol foam formulation of the synthetic vitamin D₃ analog calcipotriene and the high-potency corticosteroid betamethasone dipropionate, for topical treatment of plaque psoriasis in adults. Topical ointment and suspension formulations of the same combination have been available for many years.

Since the last Medical Letter review of generic drugs (Volume 28, page 1, 1986), the prediction that generic drugs newly approved in the USA under more relaxed federal regulations will probably be as reliable as brand-name drugs has generally been accurate. Few well-documented generic product failures have been reported. Recently, however, the equivalence of generic topical corticosteroids has been questioned.

View the Comparison Table: Some Topical Corticosteroids

Two new topical corticosteroids - fluticasone (Cutivate - Glaxo), a mediumpotency product, and halobetasol propionate (Ultravate - Westwood-Squibb), a superhigh- potency drug- were recently approved for marketing by the US Food and Drug Administration.

Calcipotriene ointment 0.005% (calcipotriol; Dovonex - Westwood Squibb), a synthetic vitamin D 3 analog previously available in Europe and Canada, has now been approved by the US Food and Drug Administration (FDA) for treatment of moderate plaque psoriasis, the most common form of the disease.

The FDA has approved calcitriol ointment (Vectical - Galderma), a vitamin D analog, for topical treatment of mild-to-moderate plaque psoriasis in adults ≥18 years old. Ointments are generally considered more potent than creams or solutions.

Atopic dermatitis (AD; also known as eczema) is frequently associated with other atopic disorders such as allergic rhinitis, asthma, and food allergy. It commonly presents in infancy and early childhood and has a relapsing course, often improving by adolescence, but sometimes persisting into (or first appearing in) adulthood or even old age.

The FDA has approved a new spray formulation of the super-high-potency corticosteroid clobetasol propionate 0.05% (Clobex - Galderma) for treatment of moderate to severe plaque psoriasis in adults. Clobetasol propionate is also available as a cream, ointment, gel, solution, foam, lotion and shampoo.

The FDA has approved a 0.3% foam formulation of the phosphodiesterase-4 (PDE4) inhibitor roflumilast (Zoryve – Arcutis) for topical treatment of seborrheic dermatitis in patients ≥9 years old. Roflumilast is the first PDE4 inhibitor to be approved in the US for this indication. It is also available in a 0.3% cream formulation (Zoryve) for treatment of plaque psoriasis and in an oral formulation (Daliresp, and generics) for treatment of chronic obstructive pulmonary disease. A 0.15% cream formulation for treatment of atopic dermatitis in patients ≥6 years old will be reviewed...