When did Relfydess get FDA approval and what pathway was used?

Relfydess received FDA approval on April 1, 2024, via the 510(k) pathway, which establishes substantial equivalence to Dysport rather than requiring new pivotal trials. This faster regulatory route means Galderma demonstrated bioequivalence and manufacturing consistency to its existing predicate device.

What is the main difference between Relfydess and Dysport?

Relfydess is a ready-to-use liquid formulation that requires no reconstitution, while Dysport ships as a powder requiring mixing with sterile saline. Both contain the same active ingredient (abobotulinumtoxinA), but Relfydess's liquid format allows room-temperature storage and eliminates prep time and reconstitution errors.

How fast does Relfydess work compared to Dysport?

Relfydess may have a slightly faster onset of 3–4 days versus Dysport's typical 5–7 days, with comparable duration of 12–16 weeks for both products. Individual variation remains substantial, and the clinical significance of this difference is modest.

Are Relfydess units the same as Dysport or Botox units?

Relfydess uses the same unit measurement as Dysport, not Botox. A typical forehead treatment with Relfydess ranges 20–25 units, matching Dysport dosing, so practices already familiar with Dysport will find the transition straightforward.

What areas is Relfydess FDA approved for?

Relfydess is FDA-cleared for glabellar lines, crow's feet, and forehead lines in adults. Practices should verify current availability and any state-specific restrictions directly with Galderma.

Does Relfydess need to be refrigerated?

No, Relfydess uses a proprietary stabilizer package that maintains potency without refrigeration, allowing room-temperature storage. This reduces cold-chain dependency and simplifies inventory management compared to powder formulations.

Is Relfydess FDA Approved? Status, Mechanism, and How It Compares to Dysport

Galderma's ready-to-use liquid botulinum toxin Type A received FDA approval in April 2024. Here's what medspa owners need to know about its formulation, clinical profile, and competitive positioning versus Dysport.

AI Inside MedSpa Intelligence · Jun 26, 2026

Yes, Relfydess received FDA approval on April 1, 2024, making it Galderma's third botulinum toxin Type A product in the U.S. market and the first ready-to-use liquid formulation cleared for aesthetic use. The approval came via the 510(k) pathway, establishing substantial equivalence to Dysport (abobotulinumtoxinA), Galderma's existing powder-reconstitution product.

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