BRIDGEWATER, N.J., Sept. 19 /PRNewswire-FirstCall/ -- Dermik Laboratories, the dermatology business of sanofi-aventis U.S. LLC, announced today the Food and Drug Administration (FDA) has accepted for filing the company's supplemental premarket approval application (s-PMA) for Sculptra(R) (injectable poly-L-lactic acid) for facial cosmetic use.
More than 150,000 people in over 30 countries worldwide have been treated with Sculptra(R), under the trade name NEW-FILL(TM). 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(R) 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 (lipoatrophy) in people with human immunodeficiency virus. It should not be used in anyone who is allergic to any ingredient of Sculptra(R). Sculptra(R) should not be injected if there is an active skin infection or inflammation in the treatment area. Side effects of Sculptra(R) may include the delayed appearance of small bumps under the skin in the treated area. Generally these bumps are not visible and may only be noticed when pressing on the treated area. Other side effects may include injection-related events at the site of injection, such as bleeding, tenderness or discomfort, redness, bruising or swelling.
About Dermik Laboratories
Dermik, the dermatology business of sanofi-aventis U.S. LLC, has pioneered the development of new pharmaceutical products for skin and nails for nearly 60 years. With a strong commitment to dermatology, Dermik continues to expand its support of cutting-edge research, employing nearly 17,000 researchers in over 20 R&D centers on three continents.
The sanofi-aventis Group is the world's third largest pharmaceutical company, ranking number one in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine, and vaccines. The sanofi-aventis Group is listed in Paris (EURONEXT: SAN) and in New York (NYSE:SNY)
Forward Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives and expectations with respect to future operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words "expect," "anticipates," "believes," "intends," "estimates," "plans" and similar expressions. Although sanofi-aventis' management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward- Looking Statements" in sanofi-aventis' annual report on Form 20-F for the year ended December 31, 2004. Other than as required by applicable law, sanofi- aventis does not undertake any obligation to update or revise any forward- looking information or statements.
Sanofi-aventis Group subsidiaries in the United States include Sanofi-Synthelabo Inc., Aventis Pharmaceuticals Inc. and Sanofi Pasteur Inc.
Contact: Terri Pedone, 908 243-6578, Terri.Pedone@sanofi-aventis.com
CONTACT: Terri Pedone of sanofi-aventis, +1-908-243-6578,