Is Letybo FDA Approved? Yes, Since February 2024

What it is approved for. Letybo'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. Using it in other areas is off-label.

What kind of product it is. Letybo is a botulinum toxin type A. The label describes it as an acetylcholine release inhibitor and a neuromuscular blocking agent. Like every botulinum toxin product, it carries a boxed warning for distant spread of toxin effect: its effects may spread from the injection site and cause symptoms consistent with botulinum toxin effects.

Dosing does not transfer from other toxins. The label states that Letybo's units of biological activity "cannot be compared to nor converted into units of any other botulinum toxin products." A practice adding Letybo next to another toxin should train injectors on Letybo's own label dosing rather than converting from a familiar product.

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, no more often than every three months. The label also tells injectors to consider the cumulative dose when a patient is being or has been treated with other botulinum toxin products.

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 Daxxify (BLA 761127, September 7, 2022). Each has its own label, indications and dosing.

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.