Galderma Receives FDA Complete Response Letter for RelabotulinumtoxinA

Regulation
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Galderma has received a Complete Response Letter from the U.S. FDA regarding its Biologics License Application for RelabotulinumtoxinA, a next-generation botulinum toxin candidate. The FDA's feedback relates to observations made during a manufacturing site inspection and analytical method optimization, while no deficiencies were noted in the safety or efficacy portions of the filing. Galderma stated it will maintain open dialogue with the agency to resolve the observations and emphasized that advancing RelabotulinumtoxinA in the U.S. remains a top priority. The FDA's comments do not affect approvals or launches in other international markets, where Relfydess, the brand name for RelabotulinumtoxinA, is already approved in 33 markets and launched in more than 20, including Europe, the Middle East, Asia, and Australia. Galderma's manufacturing site has completed 10 inspections by global regulatory authorities since 2022, supporting international launches.

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