Revance Therapeutics, Inc. – FDA CRL

The FDA issued a Complete Response Letter (CRL) to Revance Therapeutics, Inc. for its Biologics License Application (BLA 761127) for daxibotulinumtoxinA for injection, indicating the application cannot be approved in its current form under section 351(a) of the Public Health Service Act. The primary issues include unresolved product quality deficiencies identified during a recent inspection of the REVANCE THERAPEUTICS, INC. manufacturing facility, which require satisfactory resolution.

Additionally, the FDA reserved comments on the proposed prescribing information but required updated content in structured product labeling (SPL) format. Carton and container labeling also requires revision, specifically adding the statement: "ATTENTION PHARMACIST: Each patient is required to receive the enclosed Medication Guide." While the proposed proprietary name, "Daxxify," was found acceptable, it needs to be resubmitted alongside the response to other deficiencies.

A comprehensive safety update is mandated, encompassing detailed data from all nonclinical and clinical studies, including significant changes in the safety profile, new and combined adverse event tabulations, comparisons of event frequencies, updated reasons for trial discontinuations, case reports for deaths and serious adverse events, and a summary of worldwide safety experience.

Revance Therapeutics must address all identified deficiencies within one year, submitting a complete response clearly marked as "RESUBMISSION." Failure to do so may result in the application's withdrawal. The company may request a meeting to discuss the necessary steps for approval, as the product cannot be legally marketed until written approval is granted.