U.S. FDA Approves JUVEDERM® ULTRA XC for Use in Lips

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.

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SOURCE Allergan plc

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