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10/19/2005 5:09:50 PM
PRINCETON, NJ -- (MARKET WIRE) -- 05/25/2005 -- Barrier Therapeutics, Inc. (NASDAQ: BTRX), a pharmaceutical company developing and commercializing products in the field of dermatology, today announced that the U.S. Food & Drug Administration (FDA or Agency) has issued a not approvable letter dated May 24, 2005 for its NDA for Zimycan™ (0.25% miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum ointment) for the treatment of diaper dermatitis complicated by candidiasis. The FDA action is based on a single deficiency. The Agency said there is insufficient information to characterize the systemic exposure to miconazole in infants. Characterization of systemic exposure to miconazole is a component of the safety evaluation of the product.
The Agency indicated that the percutaneous absorption study that was in the application was not sufficient since the product tested used a different grade of petrolatum than that used in the pivotal clinical studies. Both grades meet the same USP specifications for petrolatum. The percutaneous absorption study in the application concluded that there was minimal systemic absorption of miconazole.
"We are disappointed and surprised by the FDA's decision; however, Barrier remains dedicated to bringing this product to the market," stated Geert Cauwenbergh, Ph.D., Chairman and CEO of Barrier Therapeutics. Dr. Cauwenbergh added, "The Company stands fully behind the safety profile of this 0.25% concentration of miconazole. Barrier will continue discussions with the Agency and is looking at all available options. We believe that one option is to conduct a second percutaneous absorption study using the current product."
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