THE WHAT? Galderma has confirmed that the global rollout of its injectable neuromodulator Relfydess remains on track, despite receiving a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA).
THE DETAILS The FDA’s Complete Response Letter relates to observations made during a pre-licence inspection of Galderma’s manufacturing facility and analytical method optimisation, with no deficiencies identified in the product’s safety or efficacy data. Galderma said it is implementing corrective and preventive actions and will continue working with the FDA to resolve the issues before resubmitting its application. The company emphasised that the regulatory observations do not affect approvals, commercial launches or ongoing regulatory reviews outside the US. Relfydess is currently approved in 33 markets and has launched in more than 20 countries across Europe, the UK, the Middle East, Asia and Australia, with further regulatory submissions progressing as planned.
THE WHY? The update demonstrates Galderma’s commitment to maintaining momentum for Relfydess internationally while addressing manufacturing-related requirements in the US. The company continues to position the product as a key component of its injectable aesthetics strategy and broader ambition to strengthen its leadership in dermatology.
Source: Business Wire
