Relfydess: The US Status, and What It Actually Is
Reviewed for medical accuracy against our Medical Review Board · Last updated 22 August 2026
Part of Botox vs Other Brands
Relfydess is not approved in the United States. It is a ready-to-use liquid botulinum toxin from Galderma, approved in 33 markets and launched in more than 20, but the FDA issued a Complete Response Letter on 1 July 2026. Galderma states that the letter concerned manufacturing and analytical methods, and that the safety and efficacy parts of the application raised no deficiencies.
If a clinic in the United States offers you Relfydess today, it is offering a product with no FDA approval. That is the single most important thing on this page, and the rest explains what the product is, why it is delayed, and what the delay does and does not tell you.
1. The US status, plainly
| Status | |
|---|---|
| United States | Not approved. Complete Response Letter issued 1 July 2026 |
| Approved worldwide | 33 markets |
| Launched worldwide | More than 20, including Europe, the UK, the Middle East, Asia and Australia |
| European Union | Approved, following a positive decision in 2024 |
| Generic name | RelabotulinumtoxinA |
| Manufacturer | Galderma |
So this is not an experimental product and it is not a product that failed. It is a product in wide use across three continents that has not yet cleared the US regulator.
2. What a Complete Response Letter actually means
A Complete Response Letter is the FDA telling an applicant that the application cannot be approved in its present form, and listing what has to be addressed. It is not a rejection of the science, and it is not a safety finding. It is a "not yet, and here is why".
What matters is which part of the application drew the comments, and Galderma's own announcement is specific about that. The letter concerned observations from a manufacturing site inspection and analytical method optimisation. On everything else the company states plainly that all other aspects of the application, including the safety and efficacy parts, did not solicit deficiencies.
Read carefully, that is an unusually reassuring kind of delay. The regulator did not question whether the drug works or whether it is safe. It raised issues with how the product is made and measured. Those are real and they have to be fixed, but they are process problems rather than product problems, and they are the kind that companies routinely resolve.
Galderma has said it plans to respond rapidly and that the US remains a priority. It has not published a timeline, and neither will we: an approval date nobody has announced is a guess, and a guess on this page would be the most likely thing to mislead you.
3. What Relfydess is
Relfydess is the brand name for relabotulinumtoxinA, a botulinum toxin type A made by Galderma, the company behind Dysport and the Restylane filler range. It is the same class of drug as Botox, Dysport, Xeomin, Jeuveau, Daxxify and Letybo: it blocks the signal from nerve to muscle so the muscle relaxes.
Where it differs is the form it arrives in, and that is the whole story of this product.
4. Why "ready to use" matters more than it sounds
Every botulinum toxin on the US market today arrives as a freeze-dried powder. Before it can be injected, someone in the clinic has to reconstitute it: add a measured amount of sterile saline, swirl it gently, and draw it up. Relfydess arrives as a liquid, already at concentration. Nothing is mixed.
That sounds like a convenience feature for the clinic. It is actually a consistency feature for you, and here is why it matters.
A "unit" of botulinum toxin is a measure of biological activity, not a volume. The labels specify how much saline to add. A clinic that adds more saline than the label specifies gets more injectable volume out of the same vial, and each millilitre carries less activity. You cannot detect that in the chair. What you might notice afterwards is a weaker result, a shorter duration, or the effect spreading further than intended, because a larger volume of a more dilute solution diffuses more.
We wrote about that at length in which Botox deals are real, because over-dilution is one of the ways a suspiciously cheap per-unit price gets delivered. A pre-mixed liquid removes that variable entirely. There is no dilution step, so there is nothing to get wrong and nothing to economise on.
Innotox, a Korean toxin, also ships as a liquid, and it holds no FDA approval either. So if and when Relfydess is approved, it would be the first ready-to-use liquid neuromodulator legitimately available in the United States.
5. The evidence behind it
The application rests on the READY programme: four randomised phase 3 trials with more than 1,900 participants between them. The indications sought in the US are moderate to severe glabellar lines, the frown lines between the eyebrows, and moderate to severe lateral canthal lines, which are crow's feet.
Two indications is worth noting in context. Letybo, the most recent toxin to be approved in the US, holds exactly one: glabellar lines only. Botox Cosmetic holds four. So Relfydess would arrive covering more ground than the newest approved competitor.
It is also already carrying real-world use behind it. A product launched in over twenty markets has been used on far more people than a trial programme alone, which is a different and in some ways better kind of evidence than a US launch product usually has on day one.
6. The six month claim, in context
The reported READY results describe onset as early as day one and durability of up to six months. Both numbers are worth handling carefully.
Onset at day one would be genuinely fast. Botox Cosmetic's own label describes chemical denervation beginning one to two days after injection and building through the first week, with the result judged at about two weeks. A day-one onset does not mean a finished result on day one; it means the effect starts sooner.
Six months is the number that will be marketed hardest, and it is the one to be most sceptical about, for the same reason we are sceptical of it elsewhere. Daxxify came to market on a long-duration claim, and in practice patient-reported duration varies widely and often lands well short of the headline. "Up to" is doing real work in that sentence: it describes the top of a range, not the middle of it.
If duration is what you care about, the honest position is to wait for independent US experience rather than trusting a launch claim, whichever brand is making it.
7. Where it is available now
Approved in 33 markets and launched in more than 20, including across Europe, the United Kingdom, the Middle East, Asia and Australia. In Europe it has been available since its 2024 approval.
That is why Americans are hearing about it. Aesthetic media covers international launches, people travel, and people follow injectors abroad. The gap between international availability and US approval is exactly the gap this page exists to fill.
One thing worth saying about being treated with it overseas: the product is properly approved in those markets, so this is not a warning about the drug. It is the ordinary caution about having any injectable treatment somewhere you cannot easily return to if something needs reviewing at the two week mark.
8. If someone offers it to you in the US
Do not accept it, and treat the offer as information about the clinic.
A product with no FDA approval being injected in the United States means one of a few things, none of them good: it was imported outside the regulated supply chain, it is counterfeit, or the person offering it does not know what they are handling. You cannot tell which by looking at a vial.
There is a real market in unapproved toxins, and several other names circulate the same way, including products sold as Neuronox, Coretox, Liztox, Innotox and Rentox. They may be entirely respectable where they are licensed. They have no business being injected into you here.
Two practical protections, both of which take a couple of minutes. Ask which product by brand name and ask to see the vial. And verify the injector's licence yourself with our 50 state verification guide. A clinic willing to inject an unapproved product is telling you something about everything else it does.
9. What to use instead, today
Five botulinum toxins are FDA approved for cosmetic use in the United States, and between them they cover everything Relfydess is being reviewed for:
| Product | Approved | Form |
|---|---|---|
| Botox Cosmetic | 2002, four cosmetic areas | Powder |
| Dysport | 2009 | Powder |
| Xeomin | 2010 | Powder |
| Jeuveau | 2019 | Powder |
| Daxxify | 2022 | Powder |
| Letybo | February 2024, glabellar lines only | Powder |
For frown lines specifically, which is the indication Relfydess is furthest along on, every one of those is an option and most are approved for it. Our guide to the brands compares them, and the thing to hold onto when you do compare is that units are not interchangeable between them, so a per-unit price tells you nothing across brands.
10. What to watch for
If you are waiting for this product, these are the things that would actually signal movement:
- Galderma announcing a BLA resubmission. The response to a Complete Response Letter restarts the review clock. That announcement is the real milestone, not press speculation.
- An FDA approval notice, which appears in the agency's own records rather than in a clinic's marketing.
- A published US prescribing information document. This is the one that matters for anything practical. Until that exists there is no US labelled dose, no US injection map and no US duration figure, whatever a launch presentation says.
What is not a signal: a clinic advertising it, a training company selling a course on it, or an influencer describing a treatment they had abroad. None of those changes its legal status here.
We will update this page when the position changes, and we will date the change. If you are reading this and the status above still says not approved, that is the current position as of the date at the top rather than an oversight.
Frequently asked questions
Is Relfydess FDA approved?
Why was Relfydess not approved in the US?
What is a Complete Response Letter?
What is relabotulinumtoxinA?
What is the advantage of a liquid botulinum toxin?
Does Relfydess really last six months?
Can I get Relfydess in the United States?
What is Relfydess approved to treat?
Is Relfydess the same as liquid Botox?
How does Relfydess compare with Letybo?
Know the count before the quote. The unit count is half the bill, and a low per-unit rate recovered by a high unit count is the commonest way a deal is not one. How to tell.
