FDA issues Complete Response Letter for Galderma's liquid neuromodulator

The FDA raised manufacturing and analytical concerns but found no clinical safety or efficacy deficiencies.

Galderma has received a Complete Response Letter from the FDA regarding its Biologics License Application for RelabotulinumtoxinA, delaying the US entry of the ready-to-use liquid neuromodulator. For domestic aesthetic clinics waiting to add this liquid toxin (marketed internationally as Relfydess) to their treatment menus, the decision pushes back the commercial launch.

The FDA's decision does not stem from clinical trial failures. The agency identified no clinical safety or efficacy deficiencies in its review. Instead, the comments focus on observations from a manufacturing site Pre-License Inspection and the optimization of analytical methods. Galderma, listed on the SIX Swiss Exchange as GALD, developed the product using its proprietary PEARL Technology. The manufacturing facility itself has successfully completed 10 inspections by international regulatory authorities since 2022.

While the regulatory delay slows down US adoption, the product already has substantial global backing. Relfydess is approved in 33 markets and has launched in more than 20, including Europe, the Middle East, and Australia. Clinical trials show that up to 39% of patients see effects on day one, and up to 75% of patients achieve results within two days.

For clinicians, this means the product remains highly viable but is temporarily out of reach for US injectors. Clinicians should expect Galderma to address these manufacturing and analytical points, with regulatory milestones and updates projected to continue through July 1, 2026. For now, plan to keep existing neuromodulators in your primary rotation, as a US launch is deferred until these manufacturing notes are resolved.

Source: Galderma, https://www.galderma.com/news/galderma-provides-progress-update-regarding-relabotulinumtoxina-regulatory-submission-united-states