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Inamed Submits Regulatory Application to
the Food and Drug Administration for Juvederm(TM) Dermal Filler
Three Formulations Included in Filing
of Final Module: Juvederm(TM) 24 HV, Juvederm(TM) 30 HV, and
(press release from Inamed Corporation)
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SANTA BARBARA, Calif.---Dec. 6, 2005--Inamed
Corporation (Nasdaq: IMDC ), a global healthcare company, today
announced that it has submitted the fourth and final module of its
Premarket Approval Application (PMA) for three formulations of
Juvederm(TM) (Juvederm(TM) 24 HV, Juvederm(TM) 30 HV and
Juvederm(TM) 30) to the U.S. Food and Drug Administration (FDA).
Juvederm(TM) is a non-animal based, cross linked hyaluronic
acid-based dermal filler which Inamed has exclusive rights to
market in the United States.
"The submission of the final module for Juvederm completes our
filing with the FDA and represents another key milestone in the
development of our facial aesthetics product portfolio," said Nick
Teti, Chairman, President and CEO of Inamed Corporation.
"Additionally, this signifies a key pipeline deliverable in
support of our stated strategy for our aesthetics franchise. We
look forward to working with the FDA to move these important
products ahead in the approval process."
The Company announced in January 2004 an exclusive licensing
agreement with the Corneal Group for its Juvederm family of
products and future product line extensions in the U.S., Canada,
and Australia and a non-exclusive agreement in certain
strategically important European markets. Juvederm is a full range
of dermal filler products based on non-animal, cross-linked
hyaluronic acid technology.
About Inamed Corporation
Inamed (Nasdaq: IMDC ) is a global healthcare company with over 25
years of experience developing, manufacturing and marketing
innovative, high-quality, science-based products. Current products
include breast implants for aesthetic augmentation and for
reconstructive surgery; a range of dermal products to treat facial
wrinkles; and minimally invasive devices for obesity intervention,
including the Lap-Band System for morbid obesity. The Company's
website is www.inamed.com.
This press release contains, in addition to historical
information, forward-looking statements. Such statements are based
on management's current estimates and expectations and are subject
to a number of uncertainties and risks that could cause actual
results to differ or differ materially from those described in the
forward-looking statements. Inamed is providing this information
as of December 6, 2005 and expressly disclaims any duty to update
information contained in this press release.
This press release contains forward-looking statements, including,
without limitation, Inamed's anticipated product development
program. These forward-looking statements involve risks and
uncertainties, which could cause actual results to differ
materially from those expressed or implied here. Readers are
referred to the documents filed by Inamed Corporation with the
Securities and Exchange Commission, specifically the most recent
reports which identify important risk factors that could cause
actual results to differ from those contained in the
forward-looking statements, including but not limited to: exposure
to product liability claims; exposure to liabilities that may not
be adequately covered by insurance; potential negative publicity
concerning product safety; changes in the economy and consumer
spending; uncertainty in receiving timely regulatory approval or
market acceptance for new products; and adverse changes in the
regulatory or legislative environment (both in the U.S. and
internationally) affecting our business. The information contained
in this press release is a statement of Inamed's present
intention, belief or expectation and is based upon, among other
things, the existing regulatory environment, industry conditions,
market conditions and prices, the economy in general and Inamed's
assumptions. Inamed may change its intention, belief or
expectation, at any time and without notice, based upon any
changes in such factors, in Inamed's assumptions or otherwise.
Inamed undertakes no obligation to review or confirm analysts'
expectations or estimates or to release publicly any revisions to
any forward-looking statements to reflect events or circumstances
after the date hereof or to reflect the occurrence of
By including any information in this press release, Inamed does
not necessarily acknowledge that disclosure of such information is
required by applicable law or that the information is material.
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