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Xolegel Approval History

  • FDA approved: Yes (First approved July 28th, 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, 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

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