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Biotech / Medical : BARRIER THERAPEUTICS, INC. (BTRX)

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From: tnsaf	5/25/2005 9:56:38 AM
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7:06AM Barrier Therapeutics gets non-approval letter from FDA for Zimycan (BTRX) 17.03 :BTRX says non-approvable letter for Zimycan for treatment of diaper dermatitis complicated by candidiasis is based on a single deficiency; FDA says there is insufficient information to characterize the systemic exposure to miconazole in infants. Co says characterization of systemic exposure to miconazole is a component of the safety evaluation of the product. Co says it its "disappointed and surprised" by the decision, says Barrier is committed to bringing the product to market, will continue discussions w/ FDA. BTRX adds that one option is to conduct a second percutaneous absorption study using the current product.

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