What happened at FDA. On July 1, 2026, Galderma announced that it had received a Complete Response Letter (CRL) on its U.S. application for relabotulinumtoxinA. A CRL means FDA has completed its review and will not approve the application in its current form. Galderma said the letter's comments related to "observations during manufacturing site inspection and analytical method optimization," and that all other aspects of the application, "including safety- and efficacy-related parts, did not solicit deficiencies to be addressed." The company said it plans to respond rapidly. It did not give a resubmission date.
Where it is approved. Galderma says Relfydess is approved in 33 markets and has launched in more than 20, including Europe, the United Kingdom, the Middle East, Asia and Australia.
What it means for U.S. practices. Until FDA approves it, Relfydess cannot be legally marketed in the United States, and product offered in the U.S. as Relfydess would be unapproved. Botulinum toxins that FDA has approved each have their own BLA, for example Xeomin (BLA 125360, first approved July 30, 2010), Jeuveau (BLA 761085, February 1, 2019), Daxxify (BLA 761127, September 7, 2022) and Letybo (BLA 761225, February 29, 2024).
Dosing will not transfer. Units of different botulinum toxin products are not interchangeable. Letybo's FDA label, for example, states that its units "cannot be compared to nor converted into units of any other botulinum toxin products." If Relfydess is approved, its U.S. dosing will come from its own label.
What to watch. A resubmission after a CRL starts a new FDA review cycle. The next hard signals are a Galderma announcement that it has resubmitted, and then an approval record appearing in Drugs@FDA.
How to verify status yourself. Search the product name in Drugs@FDA. An approved toxin shows a BLA number and an approval date, with the current label linked from the record. No record means no approval.
Business information, not medical or legal advice. Verify current status and labeling at FDA.gov before purchasing or treating.
