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Xolegel

Generic name: ketoconazole
Treatment for: Seborrheic Dermatitis

Barrier Therapeutics Announces FDA Acceptance of its New Drug Application for Sebazole Topical Gel

Seborrheic dermatitis is a skin inflammation characterized by a red, scaly, itchy rash primarily occurring on the face, scalp, hairline, eyebrows and trunk. The condition often recurs, thereby requiring re- treatment over time. Seborrheic dermatitis affects approximately 3% to 5% of the U.S. population. Barrier Therapeutics estimates that approximately 8.5 to 14.3 million people in the U.S. are affected. Current prescription therapies consist primarily of topical ketoconazole creams and topical steroids. These treatments typically require multiple applications per day over periods of up to four weeks to be effective.

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Xolegel (ketoconazole) FDA Approval History

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