The USFDA has approved Xolegel™ (ketoconazole, USP) Gel, 2% for the topical treatment of seborrheic dermatitis in immunocompetent adults and children twelve years of age and older.
Seborrheic dermatitis is a chronic inflammatory skin condition, whose cause is still unknown, but is associated with yeast infections, and other genetic and hormonal factors. Individuals with disorders of the central nervous system also appear to be prone to more extensive cases of seborrheic dermatitis.
"There are approximately 8.5 million people in the U.S. that suffer with seborrheic dermatitis and having this new convenient treatment option available to manage the symptoms associated with the disease should be of significant benefit for both physicians and patients," stated Al Altomari, Barrier's Chief Operating Officer.
Xolegel, previously referred to as Sebazole, is a topical formulation of 2.0% ketoconazole, an antifungal agent, in waterless gel. It will be launched during the fourth quarter of 2006, making it the third product to be launched in the US by Barrier Therapeutics (BTRX) this year.
Source: Barrier Therapeutics
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