Title: Botulax and Nabota: What the FDA Actually Approved Author: Arthur Harmash Published: 2026-09-29 Source: https://lymyvoyage.com/articles/botulax-nabota-fda-approval Citations: - https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761225Orig1s000ltr.pdf - https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=910e5d0e-4d0b-4de8-8e2d-97879a044181 - https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=17a914c1-e54b-4b50-965d-b0fd9111bba4 - https://www.ema.europa.eu/en/medicines/human/EPAR/nuceiva - https://www.sec.gov/Archives/edgar/data/1570562/000157056225000020/eols-20241231.htm - https://www.koreabiomed.com/news/articleView.html?idxno=32400 - https://www.koreabiomed.com/news/articleView.html?idxno=27047 - https://www.fda.gov/news-events/press-announcements/fda-warns-companies-over-illegal-marketing-botox-and-related-products - https://www.fda.gov/drugs/drug-alerts-and-statements/counterfeit-version-botox-found-multiple-states - https://www.cdc.gov/botulism/outbreaks/harmful-reactions-botox-injections/index.html --- Two botulinum toxins made in South Korea hold United States approval. The Food and Drug Administration (FDA) licensed Jeuveau in 2019 and Letybo in 2024.[^3][^2] Neither is approved under the name printed on the box at home. That matters because an approval does not attach to a molecule. It attaches to a named product, a named licence holder and a named factory. A vial labelled Nabota or Botulax has the same active substance inside as one of those two, and it is a different regulatory object. "We use Korean botox" tells you nothing about the vial. Two Korean toxins hold FDA approval, but not under the names on their Korean boxes. Which one is in the room? The FDA licensed Letybo to Hugel under US Licence 2237, made in Chuncheon. It licensed Jeuveau to Evolus under Licence 2070, manufactured by Daewoong. In Korea and most other markets, those two products are sold as Botulax and Nabota. The approvals are real, and they were not easy. Hugel filed in March 2021, received an FDA action letter in April 2023, and only cleared it with a resubmission that August. These are regulated products, not grey imports. None of this says a Korean vial is unsafe. It says no regulator outside its own market has reviewed that particular vial, and both American labels warn that units of one toxin cannot be converted into units of another. Same molecule, different regulatory objects. Approval follows the name, the licence holder and the plant. It does not follow the molecule across a border. ## What the FDA actually licensed | Name on the box | Who reviewed it | Licence holder | Licence | Approved use | |---|---|---|---|---| | Jeuveau[^3] | US Food and Drug Administration, 2019 | Evolus, Inc. | US Licence No. 2070 | Moderate to severe glabellar lines in adults | | Nuceiva[^4] | European Medicines Agency, authorised 27 Sep 2019 | Evolus Pharma B.V., Amsterdam | EU marketing authorisation | The same lines, but only in adults under 65, and only where the lines have an important psychological impact | | Letybo[^2] | US Food and Drug Administration, 2024 | Hugel, Inc., Chuncheon, Korea | US Licence No. 2237 | Moderate to severe glabellar lines in adults | | Nabota[^6] | Korea's own regulator, plus 69 countries on Daewoong's count | Daewoong Pharmaceutical | not a US licence | as authorised in each market | | Botulax[^7] | Korea's own regulator | Hugel, Inc. | not a US licence | as authorised in Korea | Jeuveau's label names Evolus as the licence holder and Daewoong Pharmaceutical in Korea as the manufacturer.[^3] Evolus holds commercial rights in the United States, the European Union and seven other territories, and shares Japan with Daewoong.[^5] Korea is not among them. Daewoong sells the product at home itself. Korea Biomedical Review reports that Nabota is the name used in Korea and most markets, Jeuveau in the United States and Nuceiva in Europe. It puts cumulative sales past 1 trillion won as of 30 June 2026.[^6] The same outlet gives Letybo's Korean name as Botulax.[^7] Both naming claims come from that publication rather than from a regulator, so they are its account. ## The same molecule, two different permissions Look at the second row of the table again. The European authorisation for Nuceiva covers adults below 65 years of age, and only where the frown lines have an important psychological impact.[^4] The American approval of Jeuveau carries no age ceiling and no psychological criterion.[^3] Same manufacturer, same substance, two regulators, two different permissions. That is what it means to say the approval is not a property of the molecule. The American approval was also not a formality. Hugel filed its application on 31 March 2021. The FDA sent an action letter on 12 April 2023, and the company's resubmission of 31 August 2023 was what completed the response.[^1] The agency licensed manufacture at Hugel's facility in Chuncheon-si, Gangwon-do. That plant is what the licence covers, not the molecule.[^1] ## What an approval keeps requiring An approval is not a one-off verdict either. It leaves obligations attached to the product. The FDA's licence for Letybo came with a postmarketing commitment. Hugel has to develop a potency test for release and stability that does not use animals, and file a final report in December 2028.[^1] Both American labels also carry the same boxed warning about distant spread of the toxin effect. It covers swallowing and breathing difficulties that can appear hours to weeks after an injection.[^2][^3] Those obligations run to the licence holder that holds the paperwork. They do not follow a vial sold under a different name in a different market. ## What "we use Korean botox" leaves out **The units do not convert.** Both American labels carry the same warning. The potency units of each product are specific to its own preparation and assay method, and "are not interchangeable with other preparations of botulinum toxin products".[^2][^3] A dose quoted in units of one toxin is not a dose in another. **The FDA has been writing to the sellers.** On 5 November 2025 it issued 18 warning letters to owners of websites illegally marketing unapproved and misbranded botulinum toxin products. The named sites include cosmo-korea.com, koreafillerexperts.com, koreanfillers.com and estaderma.com.[^8] The agency's stated reason is that products from unauthorised sources "may be unapproved, misbranded, adulterated, counterfeit, contaminated, improperly stored and transported, ineffective and/or unsafe".[^8] **People have been harmed.** Between April and December 2024, the Centers for Disease Control and Prevention recorded 17 people across 9 states with harmful reactions after botulinum toxin injections. Thirteen were hospitalised, and none died. Some products came from large online marketplaces rather than authorised suppliers, and some were self-injected.[^10] **And a counterfeit is identifiable.** The FDA documented one case in 2024 and listed the markers. The fake cartons carried lot number C3709C3. They said "Botulinum Toxin Type A" where the real product says "OnabotulinumtoxinA". They claimed 150-unit doses the manufacturer does not make, and they carried text that was not in English.[^9] That last marker is the one worth remembering. It is the one a patient can see without knowing anything about the product. ## What to ask before the injection Ask for the name on the carton and the licence number beside it, and check that the name is one your own regulator approved. In the United States that means Jeuveau under Licence 2070 or Letybo under 2237, among the six approved toxins.[^2][^3] In the European Union, Nuceiva.[^4] If the answer is Botulax, Nabota or another name from a domestic Korean range, that is not a claim about quality. It says the vial was reviewed somewhere else, under different paperwork. A recall or a liability claim would run through that other system rather than yours. And do not accept a dose expressed simply in units without the product name attached. The labels are explicit that the two do not travel together.[^2][^3] [^1]: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761225Orig1s000ltr.pdf — US Food and Drug Administration, "BLA 761225 Approval Letter, Letybo (letibotulinumtoxinA-wlbg)" (published 2024). Accessed Sep 29, 2026. [^2]: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=910e5d0e-4d0b-4de8-8e2d-97879a044181 — US National Library of Medicine, DailyMed, "LETYBO (letibotulinumtoxinA-wlbg) for injection" prescribing information, Hugel, Inc. (initial US approval 2024). Accessed Sep 29, 2026. [^3]: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=17a914c1-e54b-4b50-965d-b0fd9111bba4 — US National Library of Medicine, DailyMed, "JEUVEAU (prabotulinumtoxinA-xvfs) for injection" prescribing information, Evolus, Inc. (initial US approval 2019). Accessed Sep 29, 2026. [^4]: https://www.ema.europa.eu/en/medicines/human/EPAR/nuceiva — European Medicines Agency, "Nuceiva: EPAR summary", marketing authorisation holder Evolus Pharma B.V. (authorised Sep 27, 2019). Accessed Sep 29, 2026. [^5]: https://www.sec.gov/Archives/edgar/data/1570562/000157056225000020/eols-20241231.htm — Evolus, Inc., "Annual Report on Form 10-K for the year ended December 31, 2024", filed with the US Securities and Exchange Commission. Accessed Sep 29, 2026. [^6]: https://www.koreabiomed.com/news/articleView.html?idxno=32400 — Korea Biomedical Review, "Daewoong's Nabota tops 1 trillion won in cumulative sales, fuels global aesthetics ambitions" (published Jul 13, 2026). Accessed Sep 29, 2026. [^7]: https://www.koreabiomed.com/news/articleView.html?idxno=27047 — Korea Biomedical Review, "Hugel, BENEV launch Hugel's botulinum toxin Letybo in US" (published Mar 26, 2025). Accessed Sep 29, 2026. [^8]: https://www.fda.gov/news-events/press-announcements/fda-warns-companies-over-illegal-marketing-botox-and-related-products — US Food and Drug Administration, "FDA Warns Companies Over Illegal Marketing of Botox and Related Products" (published Nov 5, 2025). Accessed Sep 29, 2026. [^9]: https://www.fda.gov/drugs/drug-alerts-and-statements/counterfeit-version-botox-found-multiple-states — US Food and Drug Administration, "Counterfeit Version of Botox Found in Multiple States" (last updated May 2, 2024). Accessed Sep 29, 2026. [^10]: https://www.cdc.gov/botulism/outbreaks/harmful-reactions-botox-injections/index.html — US Centers for Disease Control and Prevention, "Harmful Reactions Linked to Counterfeit 'Botox' or Mishandled Botulinum Toxin Injections" (last updated Dec 17, 2024). Accessed Sep 29, 2026.