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Xolegel FDA 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 timeline for Xolegel

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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