Boey vs Botox: the EU authorization and the U.S. status are different
Boey is a type E botulinum toxin authorized in the EU. The U.S. application status and the label for BOTOX Cosmetic are different records.
Boey (trenibotulinumtoxinE) is a type E botulinum toxin authorized in the European Union for temporary improvement of moderate to severe lines between the eyebrows at maximum frown in adults when those lines have an important psychological impact. It is not the type A product BOTOX Cosmetic. AbbVie reported a U.S. FDA Complete Response Letter, and a U.S. FDA license for Boey was not found in the Purple Book when checked on November 12, 2026. EU authorization does not authorize U.S. marketing.1234
Check the jurisdiction before comparing the name
The EMA lists July 15, 2026 as the date Boey received its EU marketing authorization. That record applies to the named product and glabellar indication, not to every kind of forehead line or toxin product. AbbVie’s April update reports that the FDA sent a Complete Response Letter requesting additional manufacturing information. That description is from the applicant. A Complete Response Letter is not an approval, and the European decision cannot substitute for a U.S. FDA licensing record.123
BOTOX Cosmetic is onabotulinumtoxinA, a separate U.S.-labeled type A product. If a clinic uses “Boey Botox” as shorthand, ask it to identify the exact product and the country-specific record. Two products can be discussed for a similar appearance goal without being the same biologic or having interchangeable labeling.14
A comparison with placebo is not a comparison with Botox
The EMA summarizes two studies comparing Boey with placebo. At day seven, clinicians judged 386 of 532 Boey participants and one of 193 placebo participants to have mild or no glabellar lines and at least a two-grade improvement. The patient assessment was a separate measure. Those study counts answer whether the product changed the rated lines compared with placebo at that point. They do not establish a direct difference in onset, durability or safety against BOTOX Cosmetic.1
Keep a day-specific study result attached to its measure
The EMA summary describes when investigators rated the lines and how they defined an improvement. Those details belong with the number. A different toxin study may use another assessment day, ask patients to report a different change, or enroll a different group. A side-by-side comparison of headline percentages does not account for those design choices. Ask whether the specific claim is about clinician-rated lines, the patient’s own assessment, or how long a measured change was observed.14
If you are trying to verify an overseas claim, look for the named medicine in the regulatory record for that market. A licensed product, a pending application and a provider’s availability claim are separate questions. An update to one does not settle the others, and the date of the record matters.123
| Claim | What to verify |
|---|---|
| It is Boey | The exact name trenibotulinumtoxinE and the jurisdiction named in the record. |
| It is FDA approved | A current U.S. licensing record and the exact U.S. indication. |
| It works faster | Whether the study directly compared the named products and used the same outcome. |
| It is available here | The actual product the U.S. practice proposes, rather than an overseas announcement. |
When using a U.S. neuromodulator listing, check what the practice actually offers rather than inferring it from a headline. If you have difficulty swallowing, speaking or breathing after a botulinum toxin injection, get immediate medical attention. Keep that safety handoff separate from questions about when a cosmetic effect appears.14
Sources
- European Medicines Agency. Boey: European public assessment report. Records July 15, 2026 EU marketing authorization, exact glabellar-line indication and pooled placebo-controlled outcomes. Accessed .
- AbbVie / original applicant update. AbbVie Provides Update on TrenibotulinumtoxinE (TrenibotE) Biologics License Application in the U.S.. April 2026 applicant statement reports the Complete Response Letter and describes the manufacturing information requested. Accessed .
- U.S. Food and Drug Administration. Purple Book Database of Licensed Biological Products. FDA biologics database used to check for a licensed U.S. Boey or trenibotulinumtoxinE listing. Accessed .
- DailyMed / BOTOX Cosmetic prescribing information. BOTOX Cosmetic (onabotulinumtoxinA) prescribing information. Identifies the U.S. type A product, approved cosmetic indications and urgent warning symptoms. Accessed .