optimization. As part of its review, the FDA conducted a Pre-License Inspection (PLI) of Galderma’s manufacturing site. All other aspects of the BLA, including safety- and efficacy-related parts, did not solicit deficiencies to be addressed.

The FDA made observations during the PLI for which Galderma is putting in place corrective and preventive actions. 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 U.S. remains a top priority.

The observations do not impact approvals, launches, or regulatory reviews in other International markets.

Global launches progressing on track

As of today, Relfydess is approved in 33 markets and already launched in more than 20, including in Europe, the United Kingdom, the Middle East, Asia, and Australia, with an encouraging early launch
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