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Artes Medical

This article was originally published in The Gray Sheet

Executive Summary

ArteFill PMMA microsphere dermal filler premarket approval timeframe is pushed back to mid-2005 from the end of 2004. The firm's Dec. 1 release condemns reports of unlicensed use of the previous-generation filler Artecoll, currently marketed in Europe. San Diego-based Artes received an "approvable" letter in January, but final approval has hinged on construction and FDA inspection of a BSE-safe manufacturing facility for the bovine-based collagen product, which the firm claims treats wrinkles "permanently" (1"The Gray Sheet" Jan. 19, 2004, p. 5)...

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