The GlaxoSmithKline and Stiefel products include Evoclin Foam, Extina
Foam, Luxiq Foam, Olux Foam, Olux-E Foam, Vusion Ointment, Zovirax Capsules, Zovirax Tablets and Zovirax Suspension.
The Food and Drug Administration approved Extina (ketoconazole) Foam, 2%, for the treatment of seborrheic dermatitis in patients aged 12 years and older.
Comment: Efficacy was assessed in a study of 427 people with mild to severe seborrheic dermatitis treated with Extina foam, and another 420 treated with vehicle foam.
Comment: Efficacy was assessed in a study of 427 people, with mild to severe seborrheic dermatitis treated with Extina
foam, and another 420 treated with vehicle foam.
, a formulation of 2% ketoconazole in a proprietary foam vehicle, has been deemed nonapprovable for seborrheic dermatitis by the U.
The products from GSK and Stiefel, a GSK company, which will be marketed through Renaissance's branded division Prestium Pharma, include Evoclin (clindamycin phosphate) Foam 1%; Extina
(ketoconazole) Foam 2%; Luxiq (betamethasone valerate) Foam 0.
has received final approval for its ANDA for ketoconazole foam, 2%, the generic version of Extina
The company added Ketoconazole Foam 2% is the generic version of Extina
Ketoconazole Foam 2% indicated for the topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older.
05%; Brevoxyl-4 creamy wash (benzoyl peroxide 4%) and Brevoxyl-8 creamy wash (benzoyl peroxide 8%), packaged in the Brevoxyl acne wash kit; Extina
(ketoconazole) foam, 2%; Oilatum cleansing bar; Physiogel cream; Stieprox (ciclopirox olamine) shampoo; Revaleskin skin care products; and Sarna lotion.
Phase III clinical study was a four-week, double-blinded, active- and placebo-controlled trial that included 1,162 patients at 24 centers in the United States.