What it is approved for. Daxxify's current FDA label lists two indications: the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients, and the treatment of cervical dystonia in adult patients. Aesthetic use outside the glabellar indication is off-label.
Label dosing for glabellar lines. The label's total recommended dose is 40 Units per treatment session, given as five intramuscular injections of 8 Units each: two in each corrugator muscle and one in the procerus.
What kind of product it is. Daxxify 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), Jeuveau (BLA 761085, February 1, 2019) 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.
