FDA to Review Diaper-Dermatitis Ointment for Approval

November 1, 2005

Washington--The Food and Drug Administration has notified Barrier Therapeutics that it has deemed as a complete response the company's submission to address the FDA's May "not approvable" letter for Zimycan, a diaper-dermatitis ointment that contains miconazole nitrate.

Washington--The Food and Drug Administration has notified Barrier Therapeutics that it has deemed as a complete response the company's submission to address the FDA's May "not approvable" letter for Zimycan, a diaper-dermatitis ointment that contains miconazole nitrate.

According to a statement issued by Princeton, N.J.-based Barrier, the "complete response" designation is the FDA's indication that Barrier has provided the necessary information for the agency to complete its review of Zimycan for eventual approval.

Barrier's response to the FDA's May not-approvable letter for Zimycan, according to the company, contains information to address a deficiency the FDA detailed in its not-approvable letter regarding systemic exposure to miconazole in infants-a deficiency not addressed in Barrier's original application for approval. The company said the FDA's review of Barrier's New Drug Application (NDA) should be completed by January or February 2006.

The FDA has also approved Barrier's request to use Vusion as the brand name for the product.