Is Xeomin FDA Approved? Status, Indications, and Clinical Profile
Xeomin holds full FDA approval for dynamic wrinkles and is the only "naked" botulinum toxin formulation on the U.S. market—here's what that means for your practice.
AI Inside MedSpa Intelligence · Jun 26, 2026
Yes, Xeomin is FDA approved. The product received its initial FDA clearance in 2010 for the treatment of glabellar lines (frown lines between the brows) in adults, and has since expanded to include forehead lines and crow's feet. It is manufactured by Revance Therapeutics and distributed in the U.S. market as a direct competitor to Allergan's Botox and Galderma's Dysport.
The defining characteristic of Xeomin is its formulation as a "naked" botulinum toxin—the active neurotoxin without the accessory proteins that accompany other formulations. This distinction carries both clinical and commercial weight for practice owners.
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