DUBLIN, Oct. 1, 2015 /PRNewswire/ -- Allergan plc,
(NYSE: AGN), a leading global pharmaceutical company, today
announced that the company has received approval from the U.S. Food
and Drug Administration (FDA) to market JUVEDERM® ULTRA
XC for injection into the lips and perioral area for lip
augmentation in adults over the age of 21. JUVEDERM®
ULTRA XC instantly adds fullness to the lips and is the only dermal
filler that has proven results lasting up to one year for lip
augmentation.
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"As the leader in medical aesthetics, Allergan is committed to
continued research and development in this area," said Philippe
Schaison, Executive Vice President & President, Allergan
Medical. "Providing physicians and patients with premium products
that allow them to achieve the aesthetic results they want is
always our goal. Understanding that the desire with lip
augmentation is to achieve a natural-looking and lasting result, we
continued our research of JUVEDERM® ULTRA XC for the
lips. With this approval, JUVEDERM® ULTRA XC is now the
only filler that is approved to last up to one year in the lips
while providing natural-looking results."
Since JUVEDERM® formulations were first approved in
the United States in 2006,
physicians and patients have relied on them to correct moderate to
severe facial wrinkles and folds, such as the parentheses lines
around the nose and mouth. This heritage has continued with
introduction of JUVEDERM® VOLUMA XC for age-related
mid-face volume loss in 2013, and now, with JUVEDERM®
ULTRA XC for lip augmentation.
In clinical trials of JUVEDERM® ULTRA XC, the
majority of subjects reported improvement in the softness,
smoothness and natural look and feel of their lips through one
year. In clinical trials, 79% of subjects showed a meaningful
improvement in lip fullness three months after treatment.
Additionally, more than 78% of subjects reported an improvement in
their overall satisfaction with the look and feel of their lips at
one year after treatment.
"I often see patients who have thin lips or lips that have
become thinner over time. When discussing lip treatment with
patients, they most often express concern over being able to
achieve a natural-looking result. This is why I am very pleased
that Allergan has conducted additional research to receive FDA
approval of JUVEDERM® ULTRA XC for this new indication,"
said Dr. Suzanne Kilmer, board
certified dermatologist, clinical trial investigator and Director
of the Laser & Skin Surgery Center of Northern California. "Now, physicians and
their patients can achieve the natural-looking results they have
come to know and expect with JUVEDERM® ULTRA XC, in the
lips."
JUVEDERM® ULTRA XC is a smooth gel formulation made
up of a modified form of hyaluronic acid (HA), a naturally
occurring sugar found in the human body. The role of HA in the skin
is to deliver nutrients and help the skin retain its natural
moisture and softness. The gel formulation also contains a small
amount of local anesthetic (lidocaine), which helps to improve the
comfort of the injection.
The JUVEDERM® collection of fillers are the number
one selling dermal fillers in the United
States. For more information about JUVEDERM®
ULTRA XC and the JUVEDERM® collection of fillers, please
visit www.juvederm.com.
JUVEDERM® Ultra XC, JUVEDERM®
Ultra Plus XC, and JUVEDERM VOLUMA® XC Important
Information
INDICATIONS
JUVEDERM® Ultra XC injectable gel is indicated
for injection into the lips and perioral area for lip augmentation
in adults over the age of 21.
JUVEDERM® XC injectable gel
(JUVEDERM® Ultra XC and JUVEDERM® Ultra Plus
XC) is for injection into areas of facial tissue where moderate to
severe facial wrinkles and folds occur to temporarily add volume to
the skin, especially around the nose and mouth.
JUVEDERM VOLUMA® XC injectable gel is indicated for deep
(subcutaneous and/or supraperiosteal) injection for cheek
augmentation to correct age-related volume deficit in the mid-face
in adults over the age of 21.
IMPORTANT SAFETY INFORMATION:
CONTRAINDICATIONS
These products should not be used in patients who have severe
allergies, marked by a history of anaphylaxis or history or
presence of multiple severe allergies, and should not be used in
patients with a history of allergies to gram-positive bacterial
proteins or lidocaine.
WARNINGS
- Do not inject into blood vessels. Introduction of these
products into the vasculature may lead to embolization, occlusion
of the vessels, ischemia, or infarction. Take extra care when
injecting soft-tissue fillers; for example, inject the product
slowly and apply the least amount of pressure necessary. Rare, but
serious, adverse events associated with the intravascular injection
of soft-tissue fillers in the face have been reported and include
temporary or permanent vision impairment, blindness, cerebral
ischemia or cerebral hemorrhage, leading to stroke, skin necrosis,
and damage to underlying facial structures. Immediately stop the
injection if a patient exhibits any of the following symptoms:
changes in vision, signs of a stroke, blanching of the skin,
unusual pain during or shortly after the procedure. Patients should
receive prompt medical attention and, possibly, evaluation by an
appropriate healthcare professional specialist should an
intravascular injection occur
- Product use at specific sites in which an active inflammatory
process (skin eruptions such as cysts, pimples, rashes, or hives)
or infection is present should be deferred until the underlying
process has been controlled
PRECAUTIONS
- In order to minimize the risk of potential complications, these
products should only be used by healthcare professionals who have
appropriate training, experience, and knowledge of facial
anatomy
- Healthcare professionals are encouraged to discuss the
potential risks of soft-tissue injections with their patients prior
to treatment and ensure that patients are aware of signs and
symptoms of potential complications
- The safety and effectiveness for the treatment of anatomic
regions other than moderate to severe facial wrinkles and folds
with JUVEDERM® XC, the lips and perioral area for lip augmentation
with JUVEDERM® Ultra XC, and the mid-face with JUVEDERM VOLUMA® XC,
have not been established in controlled clinical studies
- As with all transcutaneous procedures, dermal filler
implantation carries a risk of infection. Follow standard
precautions associated with injectable materials
- The safety for use during pregnancy, in breastfeeding females,
and in patients with known susceptibility to keloid formation,
hypertrophic scarring, and pigmentation disorders has not been
studied
- The safety for use of JUVEDERM® Ultra XC and
JUVEDERM® Ultra Plus XC in patients under 18 years has
not been established
- The safety for use of JUVEDERM VOLUMA® XC in patients under 35
or over 65 years has not been established
- Use with caution in patients on immunosuppressive therapy
- Patients who are using products that can prolong bleeding (such
as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may
experience increased bruising or bleeding at treatment sites
- If laser treatment, chemical peel, or any other procedure based
on active dermal response is considered after treatment, or if the
product is administered before the skin has healed completely,
there is a possible risk of an inflammatory reaction at the
treatment site
- Patients who experience skin injury near the site of
implantation may be at a higher risk for adverse events
- The safety of JUVEDERM
VOLUMA® XC injectable gel for use in patients
with very thin skin in the mid-face has not been established
- Patients may experience late onset nodules with use of dermal
fillers, including JUVEDERM VOLUMA® XC
ADVERSE EVENTS
The most commonly reported side effects for JUVEDERM® XC
injectable gels were temporary injection-site redness, swelling,
pain/tenderness, firmness, lumps/bumps, bruising, discoloration,
and itching. For JUVEDERM® Ultra XC or JUVEDERM® Ultra Plus XC,
they were mild or moderate in severity, with a duration of 14 days
or less; and for JUVEDERM VOLUMA® XC, they were predominately
moderate in severity, with a duration of 2 to 4 weeks.
To report an adverse reaction with JUVEDERM® Ultra XC, JUVEDERM®
Ultra Plus XC, or JUVEDERM VOLUMA® XC, please call Allergan
Product Surveillance at 1-800-624-4261.
For more information, please
see JuvedermDFU.com or call the Allergan Medical
Information line at 1-800-433-8871.
JUVEDERM® Ultra XC, JUVEDERM® Ultra
Plus XC, and JUVEDERM VOLUMA® XC injectable gels are available
by prescription only.
About Allergan
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a unique, global
pharmaceutical company and a leader in a new industry model –
Growth Pharma. Allergan is focused on developing,
manufacturing and commercializing innovative branded
pharmaceuticals, high-quality generic and over-the-counter
medicines and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that
provide valuable treatments for the central nervous system, eye
care, medical aesthetics, gastroenterology, women's health,
urology, cardiovascular and anti-infective therapeutic categories,
and operates the world's third-largest global generics business,
providing patients around the globe with increased access to
affordable, high-quality medicines. Allergan is an industry leader
in research and development, with one of the broadest development
pipelines in the pharmaceutical industry and a leading position in
the submission of generic product applications globally.
With commercial operations in approximately 100 countries,
Allergan is committed to working with physicians, healthcare
providers and patients to deliver innovative and meaningful
treatments that help people around the world live longer, healthier
lives.
For more information, visit Allergan's website at
www.allergan.com.
Forward-Looking Statements
Statements contained in this press release that refer to future
events or other non-historical facts are forward-looking statements
that reflect Allergan's current perspective of existing trends and
information as of the date of this release. Except as expressly
required by law, Allergan disclaims any intent or obligation to
update these forward-looking statements. Actual results may differ
materially from Allergan's current expectations depending upon a
number of factors affecting Allergan's business. These factors
include, among others, the risks associated with acquisition
transactions; the difficulty of predicting the timing or outcome of
FDA and other regulatory approvals or actions, if any; the impact
of competitive products and pricing; market acceptance of and
continued demand for Allergan's products; difficulties or delays in
manufacturing; and other risks and uncertainties detailed in
Allergan's periodic public filings with the Securities and Exchange
Commission, including but not limited to Allergan's Quarterly
Report on Form 10-Q for the quarter ended June 30, 2015 (such periodic public filings
having been filed under the "Allergan plc" or "Actavis plc" names)
and from time to time in Allergan's other investor communications .
Except as expressly required by law, Allergan disclaims any intent
or obligation to update these forward-looking statements.
CONTACTS:
Investors:
Lisa
DeFrancesco
(862) 261-7152
Media:
Mark Marmur
(862) 261-7558
Ember Garrett
(714) 246-3525
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SOURCE Allergan plc