The Korea Herald


Hugel receives FDA approval for botulinum toxin Letybo

By Shim Woo-hyun

Published : March 4, 2024 - 17:30

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Hugel's manufacturing plant in Chuncheon, Gangwon Province (Hugel) Hugel's manufacturing plant in Chuncheon, Gangwon Province (Hugel)

Hugel, a South Korean botulinum toxin company, announced Monday that the US Food and Drug Administration has granted marketing approval for the company’s botulinum toxin, Letybo.

Hugel expects to launch Letybo in the US in mid-2024.

"The Canada launch of Letybo last year laid a solid foundation for our entry into the North American market, setting the stage for the planned US launch," an official from Hugel said.

With the latest approval, Hugel has become the first and only Korean company and one of the three botulinum toxin players globally that have received market approvals in three major aesthetic markets: the US, China and Europe. To date, the company has won approvals in 63 countries.

“The quality and credibility of Hugel’s botulinum product has been proven through the FDA’s latest approval, which requires rigorous standards,” the official said.

The US is the world’s largest botulinum toxin market accounting for over 50 percent share of the total sales globally. According to industry estimates, the US botulinum toxin market is expected to nearly double from $2.5 billion in 2023 to $4.9 billion in 2031.