As of July 2026, six neurotoxins are FDA-approved for frown lines while Galderma's Relfydess stays pending after an FDA Complete Response Letter. See the tracker.
As of July 2026, six FDA-approved neurotoxins are cleared for frown lines in the US: Botox, Dysport, Xeomin, Jeuveau, Daxxify, and Letybo. Galderma's Relfydess remains pending after a mid-2026 FDA Complete Response Letter that flagged manufacturing issues, not safety or efficacy.
The US neuromodulator market produced two updates in mid-2026 that are best read together. On July 1, 2026, Galderma disclosed that the FDA had issued a Complete Response Letter for its ready-to-use liquid neurotoxin Relfydess (relabotulinumtoxinA), delaying any US approval. Three weeks later, on July 21, 2026, Hugel Aesthetics announced a US commercial scale-up for Letybo, a toxin the FDA already approved. This tracker states plainly what is cleared and what is still pending.
Six botulinum toxin type A products are FDA-approved for the temporary improvement of moderate to severe glabellar (frown) lines in adults. In order of US cosmetic clearance, they are: Botox (onabotulinumtoxinA), approved cosmetically in 2002; Dysport (abobotulinumtoxinA), 2009; Xeomin (incobotulinumtoxinA), 2011; Jeuveau (prabotulinumtoxinA), 2019; Daxxify (daxibotulinumtoxinA), 2022; and Letybo (letibotulinumtoxinA-wlbg), approved February 2024. Every product on this list is FDA-approved. Approved indications differ: several, including Botox, Dysport, Xeomin and Daxxify, also hold additional FDA-approved cosmetic or therapeutic uses, while Jeuveau and Letybo are approved for glabellar lines only. Products are not interchangeable, and dosing units differ between brands.
Letybo launched in the US in March 2025 through a partnership with BENEV, and Hugel says more than 9,000 US practices have since integrated it. Its July 21, 2026 announcement, which added a direct sales and field-based medical affairs organization, is a commercial expansion of an FDA-approved product, not a new approval or a new indication.
Relfydess (relabotulinumtoxinA) is not FDA-approved in the United States. The FDA accepted Galderma's resubmitted Biologics License Application on February 2, 2026, covering glabellar and lateral canthal lines. Galderma then reported, on July 1, 2026, that the FDA had issued a Complete Response Letter. According to Galderma, the letter cited observations from a manufacturing site inspection and analytical method optimization, and stated that safety and efficacy aspects of the application did not solicit deficiencies. A 2023 Complete Response Letter had likewise been limited to chemistry, manufacturing and controls. Galderma says it is preparing corrective actions but has not provided a US approval timeline. Because the letter concerned manufacturing and analytical methods rather than clinical data, Galderma must resolve those items before the FDA can act again, but the company has set no public date for a resubmission. Relfydess is approved in 33 markets outside the US and launched in more than 20, including Europe, the UK and Australia, but those approvals do not confer US availability.
Watch for Galderma's corrective and preventive actions and any FDA reinspection that could resolve the manufacturing observations; no public timeline exists. Watch whether Letybo's direct US sales effort moves share in a crowded six-product field. And note that regulatory status can change, and that approval in other countries never means a product is available or approved in the US. This is a tracker, not medical advice; any treatment decision belongs with a licensed provider.