Dermatology company Galderma (SIX: GALD) announced on Wednesday that it has received a Complete Response Letter from the US Food and Drug Administration (FDA) regarding its Biologics License Application for RelabotulinumtoxinA, citing observations from a manufacturing site inspection and analytical method optimisation.

Galderma said all safety and efficacy elements of the application were not subject to deficiencies, and that the issues raised relate specifically to manufacturing site inspection observations made during the FDA pre-license inspection. Galderma said it is implementing corrective and preventive actions and will continue engagement with the regulator, with a rapid response planned.

The observations do not impact approvals, launches or regulatory reviews in other international markets. The product, marketed as Relfydess, is already approved in 33 markets and has been launched in more than 20, including in Europe, the Middle East, Asia and Australia, with early commercial momentum supported by healthcare professional feedback.