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Dermal filler approved

This article was originally published in The Gray Sheet

Executive Summary

Sanofi-Aventis' injectable poly-L-lactic acid Sculptra Aesthetic receives supplemental PMA approval for correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles, the company announced July 28. The approval was supported by a multi-center study that randomized 233 patients to either Sculptra or an approved human-derived collagen, the company said in a July 29 release. Results showed that Sculptra effects were maintained for up to 25 months after the last treatment, versus three months with the human-derived collagen. Sculptra was originally approved in 2004 for facial lipoatrophy

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