Artes Medical seeks label enhancement |
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Wed, 21 Mar 2007 15:00
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SAN DIEGO (AP) - Medical technology company Artes Medical Inc. said Wednesday it submitted additional data on its wrinkle filler, ArteFill, to the Food and Drug Administration in an effort to enhance product labeling.The company submitted results from a five-year study looking at the product's effectiveness and safety profile. ArteFill was approved by the FDA in October 2006 to minimize the appearance of wrinkles.The study involved following up on 145 patients involved in the original study, and showed statistically significant improvement in wrinkle correction five years after patients took their last ArteFill treatment, Artes Medical said.Copyright 2007 Associated Press. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
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