The dermatology specialist is seeking a biologics license from the American regulator for relabotulinumtoxinA, which is already approved under the brand name Relfydess in 33 markets.
In a brief update, Galderma said that following a manufacturing site inspection, the FDA had sent it a complete response letter NYSE:CRL. "The FDA made observations during the pre-license inspection for which Galderma is putting in place corrective and reventative actions," it noted. "Galderma will also be seeking further guidance through continued open dialogue with the FDA toward resolution of the relevant observations.
"Galderma plans to rapidly respond to the CRL and advancing relabotulinumtoxinA in the US remains a top priority."
It added that the observations, which were not specified, did not impact approvals, launches or regulatory reviews in other international markets.
That did not stop the Zurich-listed stock falling, and by 1130 BST, the shares had shed 6%.
However, Jefferies - which has a ‘buy’ rating on the stock - called the latest response from the FDA "not desirable but not too surprising - two to three CRLs in this space is not unusual. Comments are limited to manufacturing observations, [and] remediation [is] underway. We assume a nine-to-12 month delay to approval.
"While this will likely weigh on sentiment, we would view any pullback as a buying opportunity, given only a temporary softening of premium top line growth."
Founded in 1981, the owner of Cetaphil has three core divisions - injectable aesthetics, dermatological skincare and therapeutic dermatology - and sells in around 90 countries. Relfydess is being positioned as longer-lasting a rival to AbbVie’s popular Botox fillers. It was first rejected by the FDA in 2023, due to deficiencies related to chemistry, manufacturing and controls processes.