News

April 13, 2022
BOTOX® Cosmetic (onabotulinumtoxinA) Celebrates 20 Years Since First U.S. FDA Approval

Iconic Brand Was The First Product Of Its Kind To Receive U.S. Food And Drug Administration Approval In 2002 For Aesthetic Use And Is Honoring This Milestone By Celebrating Its Loyal Patients And Providers

IRVINE, Calif., April 13, 2022 /PRNewswire/ -- Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announces the celebration of a milestone moment for BOTOX® Cosmetic (onabotulinumtoxinA). April 15, 2022, will mark 20 years since the U.S. Food and Drug Administration (FDA) first approved the product to temporarily improve the look of moderate to severe glabellar lines, located between your eyebrows.1 It was the first product of its kind and has since received two additional aesthetic indications –  in 2013 and 2017 – making BOTOX® Cosmetic the first and only neurotoxin that is FDA-approved for adults to temporarily improve the look of moderate to severe lines in three areas; frown lines, crow's feet and forehead lines.2-5

"It has been remarkable to see how BOTOX® Cosmetic has evolved in 20 years, one scientific study at a time that showcases the clinical significance of this treatment," said Dr. Jean Carruthers, MD, FRCSC, FRC (Poth). "BOTOX® Cosmetic has not only changed the trajectory of my career but also the way the medical aesthetics community practices and teaches. By any account, two decades is a long time, however in medicine it is just the beginning, and I look forward to the next big milestone for BOTOX® Cosmetic."

"This celebration is about reflecting on the people who helped make BOTOX® Cosmetic a household name," said Carrie Strom, Senior Vice President, AbbVie, and President, Global Allergan Aesthetics. "We celebrate our customers, our colleagues and all the patients who have been a part of our success. We remain dedicated to BOTOX® Cosmetic, the first product of its kind on the market. We are passionate about continuing to drive this market forward and our experienced team is working closely with healthcare providers to ensure we are delivering meaningful innovations that the market needs with our commitment to ongoing research."

BOTOX® Cosmetic is bringing its celebration to the public with its first-ever Art Installation which will be on a cross-country tour. Visitors can immerse themselves in a highly visual, interactive experience that takes them on a celebratory journey of self-affirmation. The installation will be unveiled in New York City on Friday, April 22nd at 9 am ET and will be open to the public until Saturday, April 23rd before traveling to Chicago from Friday, May 6th to Sunday, May 8th and finally, Los Angeles from Friday, May 20th to Sunday, May 22nd. Starting on May 30th for eight weeks, a version of the installation will be featured at Resorts World in Las Vegas. Anyone who visits the Art Installation will be eligible to receive an exclusive BOTOX® Cosmetic offer powered by Allē®, Allergan Aesthetics' loyalty platform, while supplies last. Terms and conditions apply.

Additionally, to spotlight the people behind the product, the celebration will feature a documentary style video highlighting real patients and providers of BOTOX® Cosmetic – helping to paint a colorful picture of how and why people continue to see BOTOX® Cosmetic as a treatment for someone like them. Starting April 15th, watch the video at www.botoxcosmetic20thcelebration.com and @BotoxCosmetic on social.

To take the celebration nationwide, exclusive BOTOX® Cosmetic offerings will be available to both new and loyal BOTOX® Cosmetic patients starting in April. These offerings include a chance to win a trip for two to see Resort World's new Allē Lounge on 66, in addition to tickets to a concert. Register for the chance to win between April 15th and April 29th by visiting www.botoxcosmetic20thcelebration.com and following the steps on the site. This is a limited time offer. Terms and conditions apply.

Allergan Aesthetics, the makers of BOTOX® Cosmetic, is the exclusive aesthetics partner of Resorts World Las Vegas and will have exclusive branding rights to the property's 66th floor lounge, now known as Allē Lounge on 66, and Resorts World Theatre's meet-and-greet space, Allē Backstage. This is the first official partnership with an entitlement of this kind at Resorts World Las Vegas since its June 2021 grand opening, and Allergan Aesthetics' first-ever branding of a specific area at a major resort and live entertainment venue. The partnership is the first of its kind across the aesthetics industry.

Visit https://alle.com/ to join Allē, Allergan Aesthetics' loyalty program, which is required to attend the BOTOX® Cosmetic Art Installation and to participate in the limited-time sweepstakes and gift card offering. Terms and conditions apply. Follow us on Instagram @botoxcosmetic and @alle, in addition to using the hashtag #20yearsofbotoxcosmetic.

BOTOX® COSMETIC IMPORTANT SAFETY INFORMATION

BOTOX® Cosmetic may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX® Cosmetic:

  • Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months.
  • Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, and trouble swallowing.

BOTOX® Cosmetic dosing units are not the same as, or comparable to, any other botulinum toxin product.

There has not been a confirmed serious case of spread of toxin effect when BOTOX® Cosmetic has been used at the recommended dose to treat frown lines, crow's feet lines, and/or forehead lines.

BOTOX® Cosmetic may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of taking BOTOX® Cosmetic. If this happens, do not drive a car, operate machinery, or do other dangerous activities.

Serious and/or immediate allergic reactions have been reported. They include: itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Get medical help right away if you are wheezing or have asthma symptoms, or if you become dizzy or faint.

Do not receive BOTOX® Cosmetic if you: are allergic to any of the ingredients in BOTOX® Cosmetic (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site.

Tell your doctor about all your muscle or nerve conditions, such as ALS or Lou Gehrig's disease, myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including difficulty swallowing and difficulty breathing from typical doses of BOTOX® Cosmetic.

Tell your doctor about all your medical conditions, including: plans to have surgery; had surgery on your face; have trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; are pregnant or plan to become pregnant (it is not known if BOTOX® Cosmetic can harm your unborn baby); are breast-feeding or plan to (it is not known if BOTOX® Cosmetic passes into breast milk).

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using BOTOX® Cosmetic with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX® Cosmetic in the past.

Tell your doctor if you have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc®, Dysport®, or Xeomin® in the past (tell your doctor exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take aspirin-like products or blood thinners.

Other side effects of BOTOX® Cosmetic include: dry mouth; discomfort or pain at the injection site; tiredness; headache; neck pain; and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids and eyebrows, swelling of your eyelids and dry eyes.

APPROVED USES
BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to temporarily improve the look of moderate to severe forehead lines, crow's feet lines, and frown lines between the eyebrows in adults.

For more information refer to the Medication Guide or talk with your doctor.

To report a side effect, please call Allergan at 1-800-678-1605.

Please see BOTOX® Cosmetic full Product Information including Boxed Warning and Medication Guide.

About Allergan Aesthetics
Allergan Aesthetics, an AbbVie company, develops, manufactures, and markets a portfolio of leading aesthetics brands and products. Their aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Their goal is to consistently provide customers worldwide with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch.

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

References:

  1. Data on File. AbbVie. FDA Product Approval Information, 2019.
  2. BOTOX® Cosmetic Prescribing Information, July 2020.
  3. Dysport® Prescribing Information, 2020.
  4. Xeomin® Prescribing Information, 2020.
  5. Jeuveau® Prescribing Information, 2020.

 

SOURCE AbbVie

For further information: Media, Ember Garrett, Ember.Garrett@allergan.com, (714) 246-3525

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