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Yes. Merz's Xeomin (incobotulinumtoxinA) was first approved on July 30, 2010 under BLA 125360. Its label now covers glabellar, forehead and lateral canthal lines in adults, plus several therapeutic uses.
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Corrected September 25, 2026: An earlier version of this page described Xeomin's 2010 approval as an FDA "clearance" and named the wrong manufacturer. Xeomin is a biologic approved under a Biologics License Application, and it is made by Merz.
Yes. The U.S. Food and Drug Administration approved Xeomin (incobotulinumtoxinA) on July 30, 2010 under Biologics License Application (BLA) 125360, according to FDA's Drugs@FDA record. The application is held by Merz.
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Xeomin is made by Merz and approved under a Biologics License Application.
What it is approved for. Xeomin's current FDA label covers more indications than most toxins: chronic sialorrhea and upper limb spasticity in patients 2 years of age and older; cervical dystonia and blepharospasm in adults; and, in adults, the appearance of three upper facial lines: moderate to severe glabellar lines, horizontal forehead lines and lateral canthal lines.
Label dosing for upper facial lines. When glabellar lines, horizontal forehead lines and lateral canthal lines are treated at the same session, the label's maximum recommended dose is 64 Units.
What kind of product it is. Xeomin 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 Jeuveau (BLA 761085, February 1, 2019), 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. Xeomin (incobotulinumtoxinA) was first approved on July 30, 2010 under BLA 125360. It is made by Merz.
In adults: moderate to severe glabellar lines, horizontal forehead lines and lateral canthal lines.
64 Units when glabellar lines, forehead lines and lateral canthal lines are treated at the same session, per the label.
Business information, not medical or legal advice. Verify product status at FDA.gov.
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