Regional Regulation
このコンテンツはまだ日本語訳がありません。
Approval belongs to an exact product, presentation, jurisdiction, indication, and date. A brand sold internationally may be a prescription medicine in one country, absent from another regulator’s database, or offered online under a classification that does not authorize injection.
Regional map
Section titled “Regional map”| Region | Confirmed anchor | Main boundary |
|---|---|---|
| United States | Kybella is the only FDA-approved fat-dissolving injectable drug; approved use is adult submental fat | FDA approval does not extend to other products or body areas |
| Canada | Belkyra is listed as a marketed prescription deoxycholic-acid product | Canadian status should not be described as FDA or EU approval |
| European national markets | Deoxycholic-acid medicines have appeared as nationally authorized products; device and cosmetic claims require separate verification | There is no single interchangeable European approval label |
| South Korea | V-OLET is presented by Daewoong as a deoxycholic-acid prescription injection launched for submental fat | The current MFDS label governs Korean indication and use |
| China | A 2025 deoxycholic-acid injection approval has been reported for Rongzhi | The NMPA record, approval holder, manufacturer, and label must remain linked |
| Switzerland | Injectable Lemon Bottle products prompted an unauthorized-medicine warning | The warning also records the distributor’s position that the authentic cosmetic is external-use only |
United States
Section titled “United States”The FDA states that Kybella is the only fat-dissolving injectable drug it has approved and that the approval is limited to improvement of submental fat in adults. Its consumer communication names Aqualyx, Lipodissolve, Lipo Lab, and Kabelline among unapproved products marketed online (FDA safety communication 🔗).
The current Kybella prescribing information identifies deoxycholic acid 10 mg/mL, the adult submental indication, and risks including marginal mandibular nerve injury, dysphagia, injection-site ulceration or necrosis, alopecia, and vascular injury (FDA prescribing information 🔗).
Canada and the Belkyra identity
Section titled “Canada and the Belkyra identity”Health Canada’s Drug Product Database lists Belkyra as a marketed prescription product containing deoxycholic acid 10 mg/mL in 2 mL single-use vials. The record identifies AbbVie Corporation in the product entry (Health Canada product information 🔗).
Kybella and Belkyra belong in one regional product-family map, but the applicable label and responsible company record should still be cited separately.
Europe and classification claims
Section titled “Europe and classification claims”EMA documentation records deoxycholic acid within nationally authorized medicinal products and has published harmonized safety conclusions for Belkyra-related product information, including warnings concerning tissue damage, ulceration, and necrosis from inappropriate placement (EMA deoxycholic-acid safety conclusions 🔗).
Products presented as devices or cosmetics require a different evidence trail. A current CE certificate, intended purpose, legal manufacturer, and regulatory framework should be identified rather than summarized as approved in Europe.
South Korea
Section titled “South Korea”Daewoong lists V-OLET as a deoxycholic-acid injection containing 20 mg/2 mL and describes its 2021 Korean launch for improvement of submental fat (Daewoong product list 🔗; Daewoong R&D history 🔗). The Korean product page should be read with the current MFDS authorization rather than with Kybella instructions imported from the United States.
Rongzhi is associated with Chinese approval number 国药准字H20254519 for deoxycholic acid injection, 20 mg/2 mL, dated June 10, 2025. Publication should retain the Chinese marketing-authorization holder and contract manufacturer as separate roles and link to the regulator record when directly accessible through the NMPA database (NMPA domestic-drug query 🔗).
Switzerland and Lemon Bottle
Section titled “Switzerland and Lemon Bottle”On March 26, 2024, Swissmedic warned that Lemon Bottle products presented for injection were unauthorized medicinal products in Switzerland. Its laboratory did not detect the declared ingredients in samples obtained from different sources. A June 25, 2024 addendum records SID MEDICOS’ statement that it could not authenticate those samples and that its original Lemon Bottle ampoule was an external-use cosmetic, not intended for injection (Swissmedic warning 🔗).
This is both a classification issue and a product-authenticity issue. It should not be reduced to a generic statement that every item carrying the name is the same injectable formulation.