Hugel receives US FDA marketing approval for botulinum toxin Letybo
Overview
Hugel, a global total medical aesthetics company, announced that the company has received marketing approval from the US Food and Drug Administration (FDA) for 50 units and 100 units of its botulinum toxin Letybo.
Sign of Credibility
The FDA approval of Letybo, represents a strong recognition of Hugel’s product quality and credibility, meeting the rigorous standards by one of the world’s leading regulatory authorities. It also further underscores the company’s international leadership position.
First Korean Achiever
With the approval, Hugel becomes the first and only Korean company and one of the top 3 players globally that have garnered market approvals in three major aesthetic markets—the United States, China, and Europe. To date, it has received marketing approvals in a total of 63 countries, continue to expand its global coverage.
Market Status
The United States is the world's largest medical aesthetic market, accounting for over 50% of the total market share. According to data from global research firms, the market is expected to nearly double from USD 2.5 billion in 2023 to USD 4.9 billion in 2031.
Upcoming Tasks
- Hugel is currently in the process of finalizing the go-to-market strategy, aiming to commercially launch the product by the middle of this year.
- The launch of Letybo in Canada last year laid a solid foundation for our entry into the North American market, setting the stage for accelerated penetration into the US market.
Word from Chairman
Chairman Cha stated, “As a leading global medical aesthetic company, we are delighted to enter the United States, the world’s largest and yet still fast-growing market. We believe our long-standing track-record in South Korea, growing global market position and premium brand positioning, thought leadership in the field and the comprehensive medical affairs programs will create significant value to all constituents including our global customers, strategic partners and shareholders.”
About Hugel
Hugel is a global leader in the aesthetics and therapeutics market dedicated to providing proven, high quality products such as botulinum toxin, HA filler, PDO thread and derma cosmetics.
