Revance Resubmits BLA for DaxibotulinumtoxinA

Revance Therapeutics, Inc. has resubmitted its Biologics License Application (BLA) to FDA for DaxibotulinumtoxinA for Injection for the treatment of moderate to severe glabellar lines. The submission is in response to the Complete Response Letter (CRL) issued by FDA in October 2021.

The resubmission by Revance follows the company’s Type A meeting in December 2021 and subsequent completion of the production of three consecutive drug substance lots and one drug product lot as part of the qualification of a new working cell bank (WCB), which was required by the FDA to address outstanding observations related to the WCB and the drug substance manufacturing process.