Inside MedSpa
Yes. FDA approved Evolus's Jeuveau (prabotulinumtoxinA-xvfs) on February 1, 2019 under BLA 761085, for moderate to severe glabellar lines in adults.
| Ticker | Company | 1-year change |
|---|---|---|
| EOLS | Evolus | −15.6% |
Get the free Inside MedSpa brief by email
The free Inside MedSpa brief · no card · unsubscribe anytime. Privacy.
Corrected September 25, 2026: An earlier version of this page said Jeuveau was cleared through the 510(k) pathway and described Evolus as privately held. Both were wrong. Jeuveau is a biologic approved under a Biologics License Application.
Yes. The U.S. Food and Drug Administration approved Jeuveau (prabotulinumtoxinA-xvfs) on February 1, 2019 under Biologics License Application (BLA) 761085, according to FDA's Drugs@FDA record. The application is held by Evolus, Inc..
Get the recalls and state-law changes that hit your treatment room, in your inbox — free. Unsubscribe in one click.
The free Inside MedSpa brief · no card · unsubscribe anytime. Privacy.
Jeuveau is approved under a Biologics License Application, not cleared through 510(k).
What it is approved for. Jeuveau's FDA label indicates it for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients. That is its only approved use; other areas are off-label.
Label dosing. The recommended dose for glabellar lines is 0.1 mL (4 Units) injected intramuscularly into each of five sites, a total of 20 Units, and the label says retreatment should be no more frequent than every three months.
What kind of product it is. Jeuveau is a botulinum toxin type A, licensed as a biologic, which is why the correct FDA term is "approved," not "cleared." Like every botulinum toxin product, its label carries a boxed warning for distant spread of toxin effect.
Dosing does not transfer. Units of different botulinum toxin products are not interchangeable: FDA labels for these products state that their units cannot be compared to or converted into units of other botulinum toxin products, so dosing comes from each product's own label.
Where it sits among approved toxins. Other botulinum toxins with FDA approvals include Xeomin (BLA 125360, first approved July 30, 2010), Daxxify (BLA 761127, September 7, 2022) and Letybo (BLA 761225, February 29, 2024).
How to verify. Search the product name in Drugs@FDA. An approved toxin shows a BLA number and approval date, and the current label is linked from the record.
Business information, not medical or legal advice. Verify current status and labeling at FDA.gov before purchasing or treating.
Source: original report ↗
Yes. FDA approved Jeuveau (prabotulinumtoxinA-xvfs) on February 1, 2019 under BLA 761085. The application is held by Evolus, Inc.
The temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adults.
No. Botulinum toxins are biologics approved under a Biologics License Application; 510(k) clearance applies to certain medical devices.
Business information, not medical or legal advice. Verify product status at FDA.gov.
Get the recalls and state-law changes that hit your treatment room, in your inbox — free. Unsubscribe in one click.
The free Inside MedSpa brief · no card · unsubscribe anytime. Privacy.
https://insidemedspa.com/article/is-jeuveau-fda-approved/
No comments yet — start the conversation.
FDA decisions, recalls and the rules you operate under, drafted from the source documents and sent free by email.
Get the free brief The free Inside MedSpa brief · no card · unsubscribe anytime.