Since FDA approval in 2002, BOTOX® Cosmetic is the #1 selling product of its kind on the market.
The history of BOTOX® Cosmetic is a remarkable story of how a potent substance has been harnessed for both medical and aesthetic benefits.
Years ago, Allergan acquired a product called onabotulinumtoxinA and saw its potential for therapeutic use. The company conducted clinical trials and submitted the data to the FDA, which shepherded the product’s first approved therapeutic use.
OnabotulinumtoxinA received FDA approval for therapeutic use in 1989 and was rebranded BOTOX®. Through expanded research into aesthetic uses Allergan later commenced clinical trials to study the treatment's safety and efficacy for moderate to severe frown lines. Allergan Aesthetics has adhered to rigorous quality and safety requirements for over 30 years.
On April 15, 2002, the FDA approved BOTOX® as a temporary cosmetic treatment for moderate to severe frown lines in adults and requested the product be marketed as BOTOX® Cosmetic to distinguish cosmetic from therapeutic uses. It was the first treatment of its kind and today is the only product FDA approved to make moderate to severe frown lines, crow’s feet, and forehead lines look better in adults.
BOTOX® Cosmetic is the first and only product of its kind that's FDA-approved treatment for the temporary improvement in the appearance of moderate to severe forehead lines, frown lines, and crow's feet in adult patients.
BOTOX® Cosmetic is manufactured to the strict quality standards of 98 different countries and has become the #1 selling treatment of its kind.
Today, the community of patients receiving BOTOX® Cosmetic continues to grow, with approximately 100 million vials sold in the United States alone since 2002.
The safety and effectiveness profile of BOTOX® Cosmetic has been featured in more than 16 years of published research and described in 4700 articles in peer-reviewed scientific and medical journals. BOTOX® Cosmetic has become the most widely researched and studied treatment of its kind.