BOTOX® finally approved by FDA for forehead

ON October 5th 2017, Allergan PLC announced the FDA approval of BOTOX® Cosmetic for its third indication, the temporary improvement in the appearance of moderate to severe forehead lines associated with frontalis muscle activity in adults.

This approval makes the brand the first and only neurotoxin indicated for three facial treatment areas – forehead lines, crow’s feet lines and glabellar lines. (1) BOTOX® Cosmetic is also the only neurotoxin brand to receive approval of aesthetic indications beyond glabellar lines.

The BOTOX® Cosmetic story began in 2002 when Allergan helped establish the aesthetic market with its first FDA approval to temporarily improve the appearance of moderate to severe frown lines between the eyebrows (glabellar lines). The momentum continued in 2013 when BOTOX® Cosmetic was approved for the temporary improvement in the appearance of moderate to severe crow’s feet lines.(3,4)

The addition of this third indication furthers Allergan’s mission to continue providing patients and physicians with products designed to address specific patient needs.

“At 23MD, we’ve been using BOTOX® Cosmetic since I started providing aesthetic treatments over 10 years ago, but for years my patients have also inquired about how to treat forehead lines”. says Dr. Suha Kersh, Clinical Director at 23MD. She continues, “With this latest indication for BOTOX® Cosmetic, we now have an FDA-approved product that we already know and trust, that can improve the appearance of the forehead.”

BOTOX® Cosmetic is the brand that created a new category in facial aesthetics with its first FDA approval 15 years ago (3).

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1 BOTOX® Cosmetic Prescribing Information 2017.

2 Data On File Allergan, Inc.; Facial Injectables Patient Records Tracking Study Neurotoxins, 2016.

3 Department of Health and Human Services FDA-Approval Letter for BOTOX® Cosmetic for Glabellar Lines, 2002.

4 FDA News Release, BOTOX® Cosmetic FDA-approval letter for Crow’s Feet, 2013.


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