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