Vusion

Barrier Therapeutics Receives Not Approvable Letter From the FDA for Zimycan

Zimycan for the treatment of diaper dermatitis complicated by candidiasis, contains miconazole nitrate, which directly treats the infection, while zinc oxide and white petrolatum provide a barrier to keep excessive moisture away from the skin. This moisture contributes to the cause of the Candida infection. Diaper dermatitis, commonly known as diaper rash, is one of the most common skin conditions in infants and is observed in approximately one million pediatric outpatient visits each year in the U.S. It is estimated that more than 40% of all diaper dermatitis treated by a physician involves Candida. In the U.S., there currently is no prescription drug approved to treat diaper dermatitis complicated by candidiasis.

Source: Barrier Therapeutics, Inc.

Posted: May 2005

Related Articles

• Vusion Approved - Barrier Therapeutics, Inc. - Treatment for Diaper Dermatitis Complicated by Candidiasis - February 16, 2006
• Barrier Therapeutics Submission for Zimycan Deemed a Complete Response by FDA - October 12, 2005
• Barrier Therapeutics Submits Amendment to NDA for U.S. Regulatory Approval of Zimycan - November 29, 2004

Vusion (miconazole nitrate, zinc oxide and white petrolatum) FDA Approval History

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