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FDA Approves Forehead Botox

This is the third facial area the FDA has approved Botox for.

The U.S. Food and Drug Administration has approved of forehead Botox.

Allergan, the maker of Botox (formally called onabotulinumtoxina), said Botox has received FDA approval for temporary improvement in the appearance of moderate to severe forehead lines affiliated with forehead muscle activity in adults. According to Allergan, this makes Botox the only neurotoxin to get approval for three areas. (It’s also FDA approved for crow’s-feet lines and glabellar lines — informally referred to as 11’s, the frown lines above or in between brows.)

“Allergan recognizes that forehead lines are a top area of concern for patients,” said David Nicholson, chief research and development officer at Allergan. “Our goal in pursuing a third indication for Botox Cosmetic for the temporary improvement in the appearance of moderate to severe forehead lines was based on our desire to study the patient selection, dosing and injection pattern to help provide optimal treatment outcomes.”

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Botox is now approved for use in more than 75 countries, according to Allergan.

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The Botox news comes at a time when consumers are increasingly turning toward noninvasive cosmetic procedures, like Botox or fillers instead of full-fledged plastic surgery. Experts have emphasized the selfie — and the Kardashians — as driving forces behind the trend, especially when it comes to Millennials seeking out injectables to smooth or prevent wrinkles, or expand lips.

According to the American Society for Aesthetic Plastic Surgery, injectables overall — including Botox, but also Juvederm, Restylane and others — saw a 10 percent increase in 2016, with more than 7.3 million procedures performed. Botulinum toxin — the group Botox is in — was the number-one nonsurgical procedure for 2016, with close to 4.6 million procedures. That’s up 7.8 percent from the number of Botulinum toxin procedures performed in 2015 (more than 4.2 million), according to the ASAPS. Of those getting the Botulinum toxin injections, most — 43 percent — were between 35-50 in 2016. But a significant percentage — 15.3 percent — were between 19 and 34.