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Vusion Approval History

FDA Approved: Yes (First approved February 16, 2006)
Brand name: Vusion
Generic name: miconazole nitrate, zinc oxide and white petrolatum
Dosage form: Ointment
Previous Name: Zimycan
Company: Barrier Therapeutics, Inc.
Treatment for: Cutaneous Candidiasis

Vusion (miconazole nitrate, zinc oxide and white petrolatum) is a steroid-free ointment for the treatment of diaper dermatitis.

Development History and FDA Approval Process for Vusion

DateArticle
Feb 16, 2006Approval Vusion Approved - Barrier Therapeutics, Inc. - Treatment for Diaper Dermatitis Complicated by Candidiasis
Oct 12, 2005Barrier Therapeutics Submission for Zimycan Deemed a Complete Response by FDA
May 25, 2005Barrier Therapeutics Receives Not Approvable Letter From the FDA for Zimycan
Nov 29, 2004Barrier Therapeutics Submits Amendment to NDA for U.S. Regulatory Approval of Zimycan

Further information

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