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FDA Approves Juvederm Ultra XC

FDA Approves Juvéderm Ultra XC for Lip Augmentation

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.

"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.

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

PRECAUTIONS

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.

SOURCE Allergan plc

Posted: October 2015

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