воскресенье, 1 мая 2011 г.

Dermik Laboratories Announces FDA Acceptance Of Supplemental Filing Application For Sculptra(R)

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, fol ds and
scars.


About Sculptra(R)


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 pressin g
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.


About sanofi-aventis


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

sanofi-aventis

Комментариев нет:

Отправить комментарий