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Xolegel Approval History

FDA Approved: Yes (First approved July 28, 2006)
Brand name: Xolegel
Generic name: ketoconazole
Dosage form: Gel
Previous Name: Sebazole
Company: Barrier Therapeutics, Inc.
Treatment for: Seborrheic Dermatitis

Xolegel is a topical waterless gel formulation of the antifungal agent ketoconazole, applied once-daily for the treatment of seborrheic dermatitis in immunocompetent adults and children twelve years of age and older.

Development History and FDA Approval Process for Xolegel

DateArticle
Jul 28, 2006Approval Xolegel Gel Barrier Therapeutics, Inc. - Treatment for Seborrheic Dermatitis
Dec  9, 2005Barrier Therapeutics Announces FDA Acceptance of its New Drug Application for Sebazole Topical Gel

Further information

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