FDA approves Barrier's Xolegel

USA-based dermatology specialist Barrier Therapeutics says that the US Food and Drug Administration has approved Xolegel (ketoconazole, USP) gel, for the topical treatment of seborrheic dermatitis in immunocompetent adults and children twelve years of age and older.

The agent, previously referred to as Sebazole, is a 2% topical formulation of the antifungal ketoconazole, in a waterless gel for once-daily application. The new indication is a common skin inflammation characterized by a red, scaly, itchy rash primarily occurring on the face, scalp, hairline, eyebrows and trunk, which often recurs, requiring re-treatment over time.

Xolegel is Barrier's second approval by the FDA this year and will be the company's third product to enter the domestic market. In February, Barrier received approval for Vusion (0.25% miconazole nitrate, 15% zinc oxide, 81.35% white petrolatum) ointment for the treatment of diaper dermatitis complicated by documented candidiasis in infants four weeks and older.