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AMET works diligently to keep the following information updated with the most current medical aesthetic news.  This information has been supplied by numerous sources. AMET is not affiliated with any such sources, and the information provided does not reflect the views of AMET.  The function of this page is to simply provide information, and AMET does not accept responsibility or liability for any views/claims/rumors/errors that appears herein.  

2/1/2010
Allergan, Inc. Announces FDA Approval of JUVEDERM(R) XC Dermal Filler Formulated with Lidocaine
Allergan, Inc. Announces FDA Approval of JUVEDERM(R) XC Dermal Filler Formulated with Lidocaine
Allergan, Inc. Announces FDA Approval of JUVEDERM(R) XC Dermal Filler Formulated with Lidocaine

IRVINE, Calif., Feb 01, 2010 (BUSINESS WIRE) --
Allergan, Inc. (NYSE: AGN | Quote | Chart | News | PowerRating) today announced the U.S. Food and Drug Administration's (FDA) approval of JUVEDERM(R) XC, a new formulation of the currently FDA-approved JUVEDERM(R) dermal filler and the latest advancement(1) in hyaluronic acid (HA) dermal fillers. Allergan's new JUVEDERM(R) formulation contains the local anesthetic lidocaine to provide patients with enhanced comfort during treatment of moderate to severe facial wrinkles and folds, such as the nasolabial folds (or "parentheses") that appear around the nose and mouth. JUVEDERM(R) is the first and only hyaluronic acid dermal filler approved by the FDA to last up to one year from initial treatment(2) and number-one selling hyaluronic acid dermal filler.(3)

"As the global leader in medical aesthetics, Allergan is committed to providing the latest scientific advancements in facial aesthetic products to meet patients' demands and further optimize their experiences," said Robert Grant, Allergan's Corporate Vice President and President, Allergan Medical. "We lead innovation in the dermal filler category with the first and only smooth-consistency gel hyaluronic acid dermal filler approved by the FDA to last up to a year. Now we have added lidocaine to JUVEDERM(R) to provide the same smooth, long-lasting result, but with additional comfort for patients."

The JUVEDERM(R) XC formulation with 0.3% preservative-free lidocaine numbs the treatment area within seconds, potentially reducing the need for an additional anesthetic. JUVEDERM(R) XC provides the same smooth, long-lasting results as demonstrated with existing formulations of JUVEDERM(R), and now offers a more comfortable injection experience and potentially less time spent in the physician's office when compared to the non-lidocaine JUVEDERM(R) formulation.

"Patients want a smooth and natural-looking result from a dermal filler treatment, but as a physician I am also interested in managing my patient's discomfort during the injection. Before the introduction of JUVEDERM(R) XC it often took up to 30 minutes for an anesthetic block to take effect. In the clinical trial leading up to the FDA approval, patients reported they experienced less pain with JUVEDERM(R) XC, compared to their previous dermal filler treatment without lidocaine. So with the new formulation, patients can receive the same smooth results as demonstrated with JUVEDERM(R) but enjoy a more comfortable injection experience," said Charles Boyd, M.D., Boyd Cosmetic Surgical Institute and JUVEDERM(R) XC clinical investigator.

The FDA approval of JUVEDERM(R) XC was based on data from a multicenter, double-blind, randomized clinical trial. A total of 72 subjects were followed for two weeks after treatment with one of two JUVEDERM(R) formulations (JUVEDERM(R) XC with lidocaine or JUVEDERM(R) without lidocaine) in each nasolabial fold. In the clinical study (n=72), 93 percent of patients reported less pain when treated with the new formulation of JUVEDERM(R) compared to those treated with the non-lidocaine formulation of JUVEDERM(R).(4) JUVEDERM(R) XC was found to be more effective in reducing procedural pain during correction of facial wrinkles and folds while maintaining a similar safety and effectiveness profile to the non-lidocaine formulation of JUVEDERM(R).

Following FDA's approval, the new formulation of JUVEDERM(R) with lidocaine is available for ordering nationwide. JUVEDERM(R) is a prescription-only treatment and should be administered by a qualified medical practitioner who has been trained in JUVEDERM(R) injection techniques. To locate a trained medical practitioner in your area, please visit www.Juvederm.com.

Allergan encourages individuals interested in being treated with the JUVEDERM(R) family of products to visit www.Juvederm.com and access the JUVEDERM(R) Online Treatment Visualizer to upload a picture and help visualize how JUVEDERM(R) can potentially smooth away moderate to severe facial wrinkles and folds. This tool is for visualization and illustrative purposes only and is not a substitute for a consultation with a qualified medical practitioner.

JUVEDERM(R) Family of Products

Allergan's JUVEDERM(R) dermal filler product line includes JUVEDERM(R) Ultra and JUVEDERM(R) Ultra Plus in the United States, providing physicians with the flexibility to tailor each treatment to the particular needs of the patient. Both of these formulations will now be offered with lidocaine under the brand names, JUVEDERM(R) Ultra XC and JUVEDERM(R) Ultra Plus XC. JUVEDERM(R) XC is contraindicated in patients with a history of allergies to lidocaine.


A Brief Description of Indications for Use, Contraindications,

Warnings, Precautions, and Adverse Events for JUVEDERM(R)

Injectable Gel

Indication: In the United States, JUVEDERM(R)

injectable gel (including JUVEDERM(R) Ultra, JUVEDERM(R)

Ultra Plus, JUVEDERM(R) Ultra XC, and JUVEDERM(R)

Ultra Plus XC) is indicated for correction of moderate to severe

facial wrinkles and folds (such as nasolabial folds).

Contraindications: JUVEDERM(R) injectable gel

should not be used in patients who have severe allergies marked by

a history of anaphylaxis or history or presence of multiple severe

allergies. JUVEDERM(R) should not be used in patients

with a history of allergies to Gram-positive bacterial proteins.

JUVEDERM(R) Ultra XC and JUVEDERM(R) Ultra Plus

XC should not be used in patients with a history of allergies to

lidocaine.

Warnings: JUVEDERM(R) injectable gel should not be

injected into blood vessels. If there is an active inflammatory

process or infection at specific injection sites, treatment should

be deferred until the underlying process is controlled.

Precautions: The safety of JUVEDERM(R) for use

during pregnancy, in breastfeeding females, or in patients under

18 years has not been established. The safety and effectiveness of

JUVEDERM(R) injectable gel for the treatment of areas

other than facial wrinkles and folds (such as lips) have not been

established in controlled clinical studies. Patients who are using

substances that can prolong bleeding, such as aspirin or

ibuprofen, as with any injection, may experience increased

bruising or bleeding at injection site. Patients should inform

their physician before treatment if they are using these types of

substances. As with all skin-injection procedures, there is a risk

of infection. JUVEDERM(R) should be used with caution in

patients on immunosuppressive therapy, or therapy used to decrease

the body's immune response, as there may be an increased risk of

infection. The safety of JUVEDERM(R) in patients with a

history of excessive scarring (eg, hypertrophic scarring and

keloid formations) and pigmentation disorders has not been

studied. If laser treatment, chemical peel, or any other procedure

based on active dermal response is considered after treatment with

JUVEDERM(R) injectable gel, or if JUVEDERM(R) is

administered before the skin has healed completely after such a

procedure, there is a possible risk of an inflammatory reaction at

the treatment site.

Adverse events: The most commonly reported side effects are

temporary injection-site redness, swelling, pain/tenderness,

firmness, lumps/bumps, and bruising. Most side effects are mild or

moderate in nature, and their duration is short lasting (7 days or

less).

Important: For full safety information, please visit www.juvederm.com

or call Allergan Product Support at 1-877-345-5372.

CAUTION: Rx only.

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