As Galderma attempts to round out its injectable aesthetics portfolio with approvals to resolve crow’s feet and frown lines, the FDA spotted a few manufacturing wrinkles in its RelabotulinumtoxinA application.
The company received a complete response letter citing issues with the chemistry, manufacturing and controls (CMC) processes described in the application, Galderma said in a press release.
Galderma has “already identified” the changes needed to address the feedback, the company said.
The FDA didn’t take issue with other aspects of the filing, the company noted.
RelabotulinumtoxinA is a “highly-active, ready-to-use” liquid formulation of botulinum toxin A, which is also sold by AbbVie as Botox and by Evolus as Jeuveau.
The liquid formula skirts the traditional requirement to reconstitute the treatment from powder form, Galderma has said.
In a phase 3 trial win last summer, 82.9% of RelabotulinumtoxinA recipients saw at least a two-grade improvement in frown line severity after one month. Almost 40% reported a difference on day one.
Galderma is a skin-focused company with a foothold in fillers and acne management, plus other skincare areas.