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New Drug Application for Dapsone Topical Gel Submitted

FORT COLLINS, Colo., Sept. 1 /PRNewswire-FirstCall/ -- Atrix Laboratories, Inc. (NASDAQ:ATRX) announced today that on August 31, 2004, together with co-development partner Fujisawa Healthcare, Inc., they submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ACZONE(TM) Gel 5%(dapsone topical gel), formerly called Atrisone(TM), for the treatment of acne vulgaris.

"We are excited about the submission of this NDA for ACZONE," said David R. Bethune, Atrix's chairman and chief executive officer. "We are proud of the extraordinary hard work, commitment, and dedication of the ACZONE development team, made up of representatives from both Atrix and Fujisawa. The submission of this NDA illustrates the ability of the team to put together complex NDAs and meet the timelines associated with this challenging task."

ACZONE uses Atrix's proprietary Solvent Microparticle (SMP(TM)) delivery system to deliver dapsone, a water-insoluble compound with anti-inflammatory and anti-microbial properties. Dapsone currently is only commercially available for other indications as an oral tablet for systemic delivery due to the compound's water insolubility. Atrix's SMP system allows localized delivery of this drug. The North American market for topical acne products is over $800 million.

Source: Atrix Laboratories, Inc.

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