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Galderma Announces FDA Acceptance of RelabotulinumtoxinA Biologics License Application Resubmission

RelabotulinumtoxinA is optimized for volumetric dosing to increase ease-of-use.
RelabotulinumtoxinA is optimized for volumetric dosing to increase ease-of-use.
Dao at Adobe Stock

On February 2, 2026, Galderma announced that the Food and Drug Administration (FDA) has accepted the BLA resubmission for RelabotulinumtoxinA for frown lines and crow’s feet in adults.

The filing is based on data from the company’s READY clinical trial program (Relabotulinumtoxin Aesthetic Development Study), which composed of four trials with more than 1,900 participants. According to the trial results, RelabotulinumtoxinA delivered sustained results for six months for both frown lines and crow’s feet.

“We pioneered the development of RelabotulinumtoxinA to address the growing demand for faster-acting and longer-lasting anti-wrinkle solutions,” said Baldo Scassellati Sforzolini, MD, PhD, global head of R&D at Galderma. “We’re excited about the potential to bring this innovative neuromodulator to the US, offering advanced performance and ease of use and building on our portfolio of neuromodulators that meet the full spectrum of injector and patient needs.”

According to the company’s press release, RelabotulinumtoxinA is the first and only ready-to-use liquid neuromodulator designed to preserve molecular integrity to deliver fast onset of action. Further, it is optimized for volumetric dosing to increase ease-of-use.

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