FDA Panel Recommends Lip Indication for Medicis’ RESTYLANE®
Posted: May 8, 2011 at 3:46 pm
FDA Panel Recommends Lip Indication for Medicis’ RESTYLANE®
SCOTTSDALE, Ariz. - Medicis (NYSE:MRX) Announced that the U.S. Food and Drug Administration’s (FDA) General and Plastic Surgery Devices Advisory Panel (the Panel) has recommended with a 6-0 vote (1 abstaining) that FDA expand the approved use of RESTYLANE® Injectable Gel, a hyaluronic acid dermal filler, to include lip augmentation. RESTYLANE is currently approved to treat moderate to severe facial wrinkles and folds, such as the lines from the nose to the corners of the mouth (nasolabial folds).
“We are pleased with the Panel’s recommendation to expand the RESTYLANE label to include lip augmentation,” said Jonah Shacknai, Chairman and Chief Executive Officer of Medicis. “RESTYLANE was the first hyaluronic acid dermal filler approved by FDA for use in the United States, and has played an instrumental role in the expansion and transformation of the U.S. dermal filler market since its launch in January 2004. We believe the Panel’s recommendation for label expansion reflects confidence in the robust clinical data provided by Medicis. If FDA follows the Panel’s recommendation, RESTYLANE could become the first and only hyaluronic acid dermal filler in the U.S. indicated for use in the lips.”
About RESTYLANE
RESTYLANE is the most-studied aesthetic dermal filler in the world, and has been used in over 10 million treatments worldwide.1 Launched in the U.S. in January 2004 after approval by FDA on December 12, 2003, RESTYLANE was the first hyaluronic acid dermal filler approved in the U.S. Hyaluronic acid is a substance naturally present in the body. The hyaluronic acid in RESTYLANE closely resembles the body’s natural hyaluronic acid and is produced from a nonanimal source, making it free from animal protein, a quality which prevents disease transmission. Allergy pretesting is not necessary.
RESTYLANE has a unique gel particle structure designed for injection in the mid-to-deep dermis for structural support and lift, helping a patient look younger by smoothing away moderate to severe facial wrinkles and folds, such as nasolabial folds. RESTYLANE’s water-loving nature attracts and binds water molecules to help maintain volume.
RESTYLANE was shown to have an overall duration of effectiveness lasting up to 18 months from baseline following one repeat treatment at 4.5 or 9 months. RESTYLANE is injected into the tissue and will, in time, be resorbed by the body as the treatment results gradually wear off.
The complete RESTYLANE family of products currently approved for use in the U.S. by FDA includes RESTYLANE, RESTYLANE-L®, PERLANE® and PERLANE-L®. These products can be used individually to add volume and fullness to the skin to correct moderate to severe facial wrinkles and folds, such as nasolabial folds. Ask your healthcare professional which is right for you.
Important Safety Considerations for the RESTYLANE Family of Products
Products in the RESTYLANE family should not be used by people with previous bad allergies, particularly to certain microorganisms known as gram-positive bacteria, or by people with previous bad allergies to drugs that have required in-hospital treatment. These products should not be used by people with bleeding disorders. Injections should not be made anywhere except the skin or just under the skin. RESTYLANE-L injectable gel and PERLANE-L injectable gel should not be used by people with a known allergy to lidocaine.
Use of products in the RESTYLANE family at the site of skin sores, pimples, rashes, hives, cysts, or infection should be postponed until healing is complete. Use of the products in these instances could delay healing or make your skin problems worse. After your treatment, you might have some swelling, redness, pain, bruising, and tenderness. This will normally last less than seven days. In rare circumstances, the doctor may inject into a blood vessel, which can damage the skin. Although rare, red or swollen small bumps may occur. If you have had facial cold sores before, an injection can cause another outbreak. To avoid bruising and bleeding, you should not use the products if you have recently used drugs that thin your blood or prevent clotting. If you are pregnant, breastfeeding, or under 18 years, you should not use products in the RESTYLANE family.
Patients should be limited to 6.0 mL per treatment. The safety or effectiveness of products in the RESTYLANE family for the treatment of anatomic regions other than nasolabial folds have not been established in controlled clinical studies.
The RESTYLANE family of products is available only through a licensed practitioner. Complete product and safety information is available at http://www.RestylaneUSA.com.
About Medicis
Medicis is the leading independent specialty pharmaceutical company in the United States focusing primarily on the treatment of dermatological and aesthetic conditions. The Company is dedicated to helping patients attain a healthy and youthful appearance and self-image. Medicis has leading branded prescription products in a number of therapeutic and aesthetic categories. The Company’s products have earned wide acceptance by both physicians and patients due to their clinical effectiveness, high quality and cosmetic elegance.
The Company’s products include the brands DYSPORT® (abobotulinumtoxinA) 300 Units for Injection, PERLANE® Injectable Gel, PERLANE-L® Injectable Gel with 0.3% Lidocaine, RESTYLANE® Injectable Gel, RESTYLANE-L® Injectable Gel with 0.3% Lidocaine, DYNACIN® (minocycline HCl Tablets, USP), LOPROX® (ciclopirox) Gel 0.77% and Shampoo 1%, SOLODYN® (minocycline HCl, USP) Extended Release Tablets, VANOS® (fluocinonide) Cream 0.1%, ZIANA® (clindamycin phosphate 1.2% and tretinoin 0.025%) Gel, AMMONUL® (sodium phenylacetate and sodium benzoate) Injection 10%/10%, BUPHENYL® (sodium phenylbutyrate) Tablets and Powder, the LIPOSONIX™ system2 and the over-the-counter brand ESOTERICA®.
Medicis
480.291.5854
http://www.medicis.com
Source: Medicis
- SkinMedica Acquires Leading Professional Mineral Makeup Company Colorescience - February 5th, 2012
- Pollogen Launches the TriLipo MED Anti-aging Procedure at the EADV - December 4th, 2011
- Pollogen Receives CE Mark for TriFractional™ - An Advanced Anti-Aging Technology - December 4th, 2011
- Envy Medical Announces New Lumixyl® Revitaleyes Brightening Eye Cream - December 4th, 2011
- Le Grand Serum Ehancing Elixir - November 20th, 2011
- Evelyn Lauder Dies, Co-Founder of Pink Ribbon Breast Health Awareness - November 20th, 2011
- Sustained Aesthetic Correction Shown in Phase 2 Study with KYTHERA ATX-101 Injectable for Submental Fat - November 13th, 2011
- Portrait Plasma Skin Regeneration Resurfaces at Prestigious Symposium - September 18th, 2011
- Allergan Receives FDA Approval for First-of-Its-Kind, Fully in vitro, Cell-Based Assay for BOTOX(R) and BOTOX(R) Cosmetic - July 3rd, 2011
- Christina Hendricks Kicks Off the LATISSE® Wishes Challenge with the Goal of Raising $500,000 for the Make-A-Wish Foundation® - July 3rd, 2011
- Suneva Medical Announces Canadian Approval of Bellafill(TM) - July 3rd, 2011
- EndyMed Pro Unique Multisource RF 3DEEP® Technology - July 3rd, 2011
- Nourishing Olive Oil-Based Product that is Truly All-in-O.N.E - June 19th, 2011
- Lexli Pure Aloe: Back Bar Sizes Now Available - June 19th, 2011
- Consumer Wellness Center Launches Free Downloadable Report: 25 Amazing Facts About Food - June 5th, 2011
- GSS Delegates Cite Training and Education as Industry’s Greatest Challenge - June 5th, 2011
- The Future of Aesthetic Plastic Surgery and Anti-Aging Medicine - May 29th, 2011
- Top Manhattan Plastic Surgeon Creates App to Support Medical Tourism to New York City - May 22nd, 2011
- Is Hyperpigmentation the New Wrinkle? - May 22nd, 2011
- Drug Makers Replace Reps with Digital Tools - May 15th, 2011
- StorableOrganics.com Launches World’s First Line of Organic, Non-GMO Preparedness Superfoods - May 15th, 2011
- ATnT Wellness May - June 2011: Environmental Medicine - May 8th, 2011
- ATnT Laser & Light May - June 2011: VelaShape - May 8th, 2011
- ATnT In Practice May - June 2011: The Well Engineered Marketing Plan - May 8th, 2011
- ATnT jobFIT May - June 2011: Why Smart Employees Underperform - May 8th, 2011
- ATnT Plastic Surgery May - June 2011: Teen Surgery - May 8th, 2011
- ATnT Practice Management May - June 2011: Patient Financing - May 8th, 2011
- ATnT Practice Management May - June 2011: Medical & Spa - May 8th, 2011
- ATnT Organics & Green May - June 2011: Organic Eating Pt. II - May 8th, 2011
- ATnT Plastic Surgery May - June 2011: Regenerative Aesthetics - May 8th, 2011
- ATnT Laser & Light May - June 2011: Viora Reaction System - May 8th, 2011
- ATnT Anti-Aging May - June 2011: Spring Clean for the Body - May 8th, 2011
- ATnT Aesthetician May - June 2011 - May 8th, 2011
- ATnT Dermatology May - June 2011: Evolution of Medical Retail - May 8th, 2011
- ARTAS System Receives FDA Clearance for Groundbreaking Technology Treating Hair Loss - May 8th, 2011
- SOLO Flashlight: A Great Instrument for the Cosmetic Physician - May 8th, 2011
- Teen Girls, Young Women and the Dangers of Indoor Tanning - May 8th, 2011
- DECLÉOR Introduces Resurfacing Gel-Peel - May 8th, 2011
- Goldfaden Introduces Alpine Rose Stem Cell Cream - May 8th, 2011
- Contento Marketing Adds GliSODin Skin Nutrients to Client Roster - May 1st, 2011
- Growing Demand for China’s Plastic Surgery Industry - May 1st, 2011
- Lumenis Launches New AcuPulse with MultiMode™ Technology - April 10th, 2011
- NaturalFill® Natural Breast Enhancement™ - April 10th, 2011
- March 2011 Special Report - Energist Portrait PSR - April 3rd, 2011
- Beauty Giants Help During The Japan Crisis - March 27th, 2011
- ATnT Wellness March-April 2011: Weight Loss - March 13th, 2011
- ATnT Featured Med Spa March-April 2011: Saudé - March 13th, 2011
- ATnT Anti-Aging March-April 2011: Staying Youthful - March 13th, 2011
- ATnT Dermatology March-April 2011: Prevena - March 13th, 2011
- ATnT Dermatology March-April 2011: Mineral Makeup - March 13th, 2011
- ATnT In Practice March-April 2011: Fee for Service - March 13th, 2011
- ATnT jobFIT March-April 2011: New Hires - March 13th, 2011
- ATnT Laser & Light Mar-Apr 2011: Pellevé - March 13th, 2011
- ATnT Laser & Light Mar-Apr 2011: Laser Safety - March 13th, 2011
- ATnT Organics & Green Mar-Apr 2011: Organic Eating - March 13th, 2011
- ATnT Organics & Green Mar-Apr 2011: Green Cleaning - March 13th, 2011
- ATnT Plastic Surgery Mar-Apr 2011: Multiple Procedures - March 13th, 2011
- ATnT Plastic Surgery Mar-Apr 2011: Hair Restoration - March 13th, 2011
- ATnT Practice Management Mar-Apr 2011: Profiting from Wellness - March 13th, 2011
- ATnT Anti-Aging March-April 2011: Botexting - March 13th, 2011
- ATnT Anti-Aging March-April 2011: LashDip - March 13th, 2011
- Syneron Named to MDB Capital Group’s “Best & Brightest” List - March 6th, 2011
- The Montage of Laguna Beach New “Studio Garden” - February 27th, 2011
- Practice Management Jan-Feb 2011: Marketing Your Medical Spa - February 14th, 2011
- Wellness Jan-Feb 2011: Reversed Aging - February 14th, 2011
- Cordelia Donovan, Inc. Announces Filming Documentary, Suck My Fat - February 14th, 2011
- Medical Societies Announce Coalition for Patient Safety in Cosmetic Medicine and Aesthetic Surgery - February 14th, 2011
- LashDip: The Secret to Lush, Full, Dark, Long Lashes is the Hottest Trend - February 14th, 2011
- Europe Makes Cross-Border ‘Health Tourism’ Easier - February 14th, 2011
- Paula Simpson of GliSODin Featured on Good Morning America, Health - February 14th, 2011
- Saks Fifth Avenue Partners with neuveauBROW - February 14th, 2011
- Non-Surgical Facial Procedures Spike Dramatically in 2010 - February 14th, 2011
- AAD Annual Gold Triangle Awards in New Orleans Febuary 2011 - February 14th, 2011
- Lumixyl Special Report - February 2011 - February 14th, 2011
- Research Reveals VASER Lipo® Yields Fat as Viable As Conventional Liposuction - February 14th, 2011
- Anti-Aging Jan-Feb 2011: Fitness & Surgery - February 14th, 2011
- Dermatology Jan-Feb 2011: Winter Skin - February 14th, 2011
- In Practice Jan-Feb 2011: A Year in Review - February 14th, 2011
- jobFIT Jan-Feb 2011: Developing Employee Performance - February 14th, 2011
- Laser & Light Jan-Feb 2011: Principles of Ultrasound - February 14th, 2011