First-time generic formulations approved for Ultravate®, Elocon®, Locoid®, and Loprox®

Journal of Drugs in Dermatology, March-April, 2005

The FDA has approved first-time generic formulations for halobetasol propionate 0.05% ointment and cream (made by Taro Pharmaceuticals USA, Inc., Altana, Inc., and Agis Industries, Ltd). The product was previously marketed only under the brand name Ultravate, made by Westwood Squibb. Halobetasol propionate 0.05% is a super-high-potency corticosteroid indicated for the treatment of inflammation and pruritus in corticosteroid-responsive dermatoses in patients aged 12 years and older.

The FDA approved a first-time generic formulation for mometasone furoate cream USP 0.1% (made by Taro Pharmaceuticals USA, Inc.), which was previously marketed only under the brand name Elocon, made by SP Schering Corp. Mometasone furoate cream 0.1% is a medium-potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients aged 2 years and older. The FDA also approved a first-time generic formulation for hydrocortisone butyrate ointment USP 0.1% (made by Taro Pharmaceutical Industries, Inc.). The product's brand name is Locoid, made by Ferndale Laboratories. Hydrocortisone butyrate cream is indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Finally, the FDA approved a first-time generic formulation for ciclopirox cream USP 0.77% made by Altana, Inc. The brand name is Loprox, made by Medicis Pharmaceutical Corp. Ciclopirox cream is indicated for the treatment of cutaneous dermatophyte infections including tinea pedis, tinea cruris, tinea corporis, candidiasis, and tinea (pityriasis) versicolor.