Botulax? I’ve never heard of it.
In the US it’s Letybo, FDA-approved for frown lines.
And Nabota?
That’s Jeuveau in the US. Also FDA-approved.
So it’s similar to Botox?
It passed the same kind of FDA trial.
Short answer:
- Botulax is sold in the US as Letybo, FDA-approved (BLA 761225, February 2024) for frown lines; Nabota is sold as Jeuveau (BLA 761085, February 2019), approved for the same use.
- A toxin can’t get in on paperwork the way a device does with a 510(k). It needs a BLA: large trials in real people against a placebo. Letybo’s trials enrolled 1,276 people, Jeuveau’s 654.
- So in Korea, Botulax or Nabota is the same company’s toxin that carries a US label. But units differ by brand and can’t be swapped, and your result depends on dose, injection points and the injector.
What is the difference between a 510(k) and a BLA?
In my post on Korean RF devices, I explained that machines like Oligio passed the FDA through a 510(k). That is a paper review: “this machine is close enough to one already sold in the US.” No human trial is required. The FDA word is “cleared.”
A toxin is a drug, a biologic. “Close enough” is not allowed. The company files a Biologics License Application (BLA) and has to show, in its own trials, that the drug works better than a placebo shot and is safe enough. The FDA word is “approved.”
Think of it this way: a bike passes by looking like another bike. A medicine needs a report card from hundreds of people.
Which Korean toxins passed that test?
Letybo (letibotulinumtoxinA-wlbg), made by Hugel. Korean name: Botulax.
- BLA 761225, approved 29 February 2024 [4]
- Use: temporary improvement of moderate to severe frown lines (glabellar lines)
- Trials: three phase 3 studies (BLESS I, II, III), 1,276 people enrolled, 957 on Letybo and 319 on placebo [1]
Jeuveau (prabotulinumtoxinA-xvfs), made by Daewoong, sold by Evolus. Korean name: Nabota.
- BLA 761085, approved 1 February 2019 [4]
- Use: temporary improvement of moderate to severe frown lines
- Trials: two phase 3 studies (EV-001, EV-002), 654 people enrolled, 492 on Jeuveau and 162 on placebo [2]
For comparison, Botox Cosmetic (Allergan, BLA 103000) is approved for frown lines, crow’s feet, forehead lines and, since October 2024, neck bands (platysma) [3]. So in the US, Letybo and Jeuveau are approved for frown lines only. Using them around the eyes or forehead falls under Korean approval or the doctor’s judgement.
Does that make them the same as Botox?
What the FDA accepted is that each one beat placebo and was safe enough. These were not head-to-head trials against Botox. So the accurate sentence is not “it’s the same as Botox.” It is “it passed the same kind of approval trial that Botox did.” In practice, a toxin that beat placebo in that kind of trial can be expected to work. What differs is the units and the hands.
The labels also say plainly that each brand’s units belong to its own test method and cannot be converted into another toxin’s units [1][2]. You can’t assume 20 units of Botox equals 20 units of Botulax. I go through the brand-by-brand units in my guide to Korean Botox brands.
What about Korean toxins without US approval?
For Meditoxin (exported as Neuronox), Innotox, Liztox and Coretox, I found no US approval record in the FDA drug database (Drugs@FDA). It does not mean they are unsafe to use in Korea. They are approved by Korea’s Ministry of Food and Drug Safety (MFDS). I wrote about one of them in Innotox vs Botox.
What should I ask before the injection?
- “Which product is it today?” Ask for the brand on your chart or receipt. Back home, you can tell your doctor “Letybo, sold in Korea as Botulax.”
- “How many units?” Write the brand and units down together. Why brands kick in at slightly different times is in how long Botox takes to work.
What I tell my patients
If you want a product with US approval, Botulax and Nabota are the two Korean toxins that have FDA labels. Even with the same product, results depend on the dose, where it goes, and who injects it (clinical judgement). The labels list side effects such as headache and drooping eyelid, and spread of toxin effect is a boxed warning for every botulinum toxin [1][2].
Have a question about your own case? Ask me on LINE or by email — details on the Contact page.
FAQ
Is Botulax FDA approved?
Yes, under the US name Letybo. Hugel’s letibotulinumtoxinA was approved on 29 February 2024 (BLA 761225) for moderate to severe frown lines. The name “Botulax” itself does not appear on the US label.
Is Nabota FDA approved?
Yes, as Jeuveau. Daewoong’s prabotulinumtoxinA, sold in the US by Evolus, was approved on 1 February 2019 (BLA 761085) for moderate to severe frown lines.
Is Meditoxin FDA approved?
I found no US approval record for Meditoxin (Neuronox) in Drugs@FDA. It is approved in Korea by the MFDS.
Is Letybo the same as Botulax?
Letybo is the US name for Hugel’s toxin, sold in Korea as Botulax. Hugel’s US application was filed under the Botulax name before approval as Letybo (BLA 761225). Units and results still depend on the dose and injector.
References
- US FDA. LETYBO (letibotulinumtoxinA-wlbg) prescribing information, BLA 761225, 02/2024. accessdata.fda.gov
- US FDA. JEUVEAU (prabotulinumtoxinA-xvfs) prescribing information, BLA 761085, 2019. accessdata.fda.gov
- US FDA. BOTOX Cosmetic (onabotulinumtoxinA) prescribing information, BLA 103000, revised 10/2024. accessdata.fda.gov
- Drugs@FDA. BLA 761225 and BLA 761085, approval history. 761225 · 761085
Disclaimer: This is general information, not a diagnosis or a treatment plan. Brand names are discussed for information only and are not endorsements. Injections and prescription medicines should be chosen and given only by a licensed professional who has examined you, and what suits another person may not suit you.
14 years in practice · replies to messages herselfA doctor in Korea, in practice since 2012 — your K-Beauty Doc. Physician in non-surgical aesthetic medicine, practising in Ansan, South Korea. Every article here is written from clinical practice and the published literature. Not medical advice.
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