FDA Accepts Revance's BLA Resubmission for DaxibotulinumtoxinA

The PDUFA goal date is September 8, 2022.

The U.S. Food and Drug Administration (FDA) accepted Revance’s Biologics License Application (BLA) resubmission for DaxibotulinumtoxinA for Injection for the treatment of moderate to severe glabellar lines.

The FDA designated the BLA as a Class 2 resubmission, which has a six-month review period and includes a required reinspection of the company’s manufacturing facility. 

Revance was provided a Prescription Drug User Fee Act (PDUFA) goal date of September 8, 2022