By Adria Calatayud
Galderma's application for its latest product to rival AbbVie's Botox was declined by the U.S. Food and Drug Administration after a manufacturing-site inspection, three years after a prior submission was also turned down.
The Swiss skincare specialist said Wednesday that it is putting in place corrective and preventive actions to address the FDA's comments in its complete response letter declining the application. Galderma said the FDA made observations during an inspection of the company's manufacturing site as part of the review of its application for RelabotulinumtoxinA, which is marketed in some countries as Relfydess.
"Galderma plans to rapidly respond to the [FDA's complete response letter] and advancing RelabotulinumtoxinA in the U.S. remains a top priority," it said.
The company said Relfydess is already approved in some countries in Europe, the Middle East and Asia, and that the FDA's observations don't affect approvals, launches, or regulatory reviews in other markets.
In 2023, the FDA also declined Galderma's application for the product, pointing out deficiencies related to chemistry, manufacturing, and controls processes, the company said at the time.
Write to Adria Calatayud at adria.calatayud@wsj.com