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Atrix/Fujisawa submit Aczone

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Atrix' Aczone (dapsone 5% gel) could clear FDA by mid-2005. Atrix and development partner Fujisawa submitted the NDA for the topical acne treatment Aug. 31 for standard review. Dapsone is currently available only as an oral tablet "due to the compound's water insolubility," Atrix says. Aczone (formerly Atrisone) employs Atrix' proprietary solvent microparticle delivery technology. Aczone is also in early clinicals for treatment of rosacea...
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