Barrier gets FDA approval for Xolegel gel

By Elaine Rigoli

Tampa, Fla., July 28 - Barrier Therapeutics, Inc. said the Food and Drug Administration has approved Xolegel (ketoconazole, USP) gel, 2% for the topical treatment of seborrheic dermatitis in immunocompetent adults and children 12 years of age and older.

Xolegel, previously referred to by the company as Sebazole, is a topical formulation of 2.0% ketoconazole, an antifungal agent, in a waterless gel for once-daily application.

Seborrheic dermatitis is a common skin inflammation characterized by a red, scaly, itchy rash primarily occurring on the face, scalp, hairline, eyebrows and trunk. The condition often recurs, requiring re-treatment over time.

The company said Xolegel is the first prescription gel formulation of ketoconazole approved in the United States.

Xolegel is Barrier's second product approved by the FDA this year and will be the company's third marketed product in the United States. 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.

Barrier is a pharmaceutical company with headquarters in Princeton, N.J.

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