If you've been researching botulinum toxin products for your clinic or personal treatment, chances are you've come across Botulax, one of the leading neurotoxins produced in South Korea. It's often praised for its reliability, affordability, and comparable results to Western brands —but a common question keeps coming up:
"Is Botulax FDA approved?"
Let's break it down clearly and answer that—and a few other questions—based on the most current information.
In February 2024, the U.S. Food and Drug Administration officially approved Letybo, the U.S. brand name for Botulax, for the treatment of moderate to severe glabellar lines (frown lines) in adults. Letybo is manufactured by Hugel, the same South Korean company behind Botulax.
This approval followed a rigorous multi-year process, including:
Preclinical and Phase III clinical trials involving over 1,000 participants in the U.S. and Europe
A Complete Response Letter in 2023 requesting improvements in Hugel's manufacturing facilities and data submissions
Final re-submission and approval in February 2024, confirming its safety and efficacy on par with other type A botulinum toxin products.
Botulax is now among a small number of FDA-approved botulinum toxin products in the U.S., joining the ranks of Botox, Dysport, and Xeomin.
Before its U.S. debut, Botulax was already widely approved and used in:
South Korea
European Union (CE certification)
Brazil, Mexico, Indonesia, Thailand, and more
While Botulax is not currently MHRA-approved in the UK, it is widely distributed in EU and Asian markets, and its FDA approval is likely to accelerate regulatory acceptance elsewhere.
So, if you're asking "Is Botulax FDA approved in the UK?" — not yet, but the approval in the U.S. is a strong indicator of global regulatory confidence.
Botulax's U.S. approval is not just symbolic—it's strategic.
Since its FDA clearance:
Shipments began in July and September 2024 to U.S. clinics
Hugel's botulinum toxin business grew by 41% year-over-year, driven by international sales
The company aims to capture 10% of the U.S. botulinum toxin market within 3 years.
Botulax is considered a cost-effective alternative with comparable efficacy, making it especially appealing to clinics looking for better ROI without compromising patient results.
Yes. Like all botulinum toxin products, Botulax (Letybo) is prescription-only, and should only be used by qualified healthcare providers.
Due to rising popularity, counterfeit products have appeared in some regions, especially when buying online—so it's critical to source through verified, legal suppliers.
Practitioners around the world have praised Botulax for its:
Smooth injection
Predictable onset and duration
Low rate of side effects
Affordable pricing
️ "We've used Botulax 100 and 200 units regularly in our clinic. Patients love the results—and the cost savings are a big plus." — Aesthetic RN, New York
️ "It's just as effective in my experience, but with better wholesale options. Especially now that it's FDA approved." — Clinic Owner, Los Angeles
Yes—but be careful.
You can buy Botulax botulinum toxin online from Korea, but only from trusted suppliers that offer authentic Hugel products. Now that Letybo is FDA approved in the U.S., expect more regulated and reliable distribution in North America.
Whether you're buying Botulax 100, 200, or 300 Units, always confirm your supplier is verified.
For trusted quality and safety, choose Dermax—a professional supplier with 17 years of experience in premium aesthetic products.
✅ Authentic Botulax
✅ Secure & Discreet Shipping
✅ Competitive Pricing
Order Botulax now and experience reliable service!
Contact us today: support@dermaxmed.com
Don't compromise—trust the experts at Dermax for your Botulax needs!
Question | Answer |
Is Botulax FDA approved? | Yes, as Letybo (approved in February 2024) |
Is Botulax approved in the UK? | Not yet MHRA-approved, but widely used in Europe |
Is Botulax prescription-only? | Yes, always use under licensed medical supervision |
Is Botulax safe? | Yes, proven in global clinical trials |
Where can I buy Botulax? | Through trusted Korean suppliers or U.S. distributors |
Botulax has officially entered the big leagues. With FDA approval under the Letybo name, its credibility, accessibility, and demand are only growing. If you're a practitioner or distributor looking for a high-quality, clinically proven, and cost-effective botulinum toxin—Botulax is worth serious consideration.
Want wholesale pricing or need help sourcing authentic Botulax? Contact us here for expert support and the latest availability.
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