Botox Is Finally Approved by FDA for Use in the Forehead Area

Photo Credits: ShutterStock | Model Used for Illustrative Purpose Only

With new uses of Botox Cosmetic being explored every day (like a cure for depression, a temporary fix for a gummy smile and the unfortunately named Scrotox), it’s hard to believe the drug isn’t already approved by the U.S. Food and Drug Administration for all of its many indications. Even though the substance has been around since the '50s and '60s, it was only in 2002 that Botox Cosmetic received approval for treating frown lines and facial wrinkles (and it was just approved for use on crow’s-feet in 2013). Now, the FDA has approved the brand for use to treat forehead lines as well, making it the only neuromodulator on the market approved for use in wrinkles in three areas of the face—forehead lines, crow's-feet and glabellar lines.

If it seems like Botox Cosmetic has been treating forehead wrinkles for a very long time, that’s because it has. Doctors have been using the drug to treat forehead lines “off-label,” meaning outside of its FDA-approved use, for decades. Once a drug obtains FDA-approval for one condition, a licensed physician can legally prescribe it for other conditions that they believe can benefit from the drug. The recent FDA-approval for the use of Botox Cosmetic in the forehead area just means that the drug has passed numerous clinical trials and is proven to do what doctors and patients around to the world already know it can, temporarily banish lines and wrinkles.

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"As a physician, I've been using Botox Cosmetic since it was FDA-approved in 2002, but for years my patients have also inquired about how to treat forehead lines. With this latest indication for Botox Cosmetic, I have an FDA-approved product I already know and trust, that can improve the appearance of the forehead," says Boca Raton, FL, oculoplastic surgeon and lead clinical trial investigator, Steven Fagien, MD.

According to the American Society of Plastic Surgeons, more than 7 million Botox Cosmetic treatments were administered in 2016, making it the number-one noninvasive cosmetic treatment in the country. And with younger patients turning to the injectable for preventive measures, we forsee more FDA-approved uses in the years to come for the treatment Time Magazine called “The Drug That’s Treating Everything.”

1 Comment
  • Anna-Laura
    Posted on

    It just got approved for the forehead?! That has been off-label for years! WOW!

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