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SNY – FDA Accepts Sculptra PMA

[If approved for general cosmetic use, Sculptra will compete with such products as Restylane from MRX. Sculptra was approved by the FDA two years ago as a treatment for “facial wasting” in AIDS patients.]

http://biz.yahoo.com/ap/060919/sanofi_aventis_fda.html?.v=1

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September 19, 10:09 am ET

BRIDGEWATER, N.J. (AP) -- Sanofi-Aventis' Dermik Laboratories dermatology unit said Tuesday the Food and Drug Administration has accepted the company's supplemental premarket approval application for Sculptra, an injectable acid for facial cosmetic use.

The company said more than 150,000 people in over 30 countries have been treated with Sculptra, under the tradename New-Fill. It was approved in Europe in 1999 to increase volume, particularly for the correction of skin depression, including skin creases, wrinkles, folds and scars.

Sculptra is a synthetic, biocompatible, bioabsorbable material that is naturally broken down by the body over time. It was approved in the U.S. in 2004 for restoration and/or correction of the signs of facial fat loss, or wasting, in people with HIV.
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