Revance Therapeutics Inc, a biotechnology company focused on innovative aesthetic and therapeutic offerings, announced it has resubmitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for DaxibotulinumtoxinA for Injection for the treatment of moderate to severe glabellar lines in response to the Complete Response Letter (CRL) issued by the FDA in October 2021.
The resubmission follows the company’s Type A meeting in December 2021 and the 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 the outstanding observations related to the WCB and the drug substance manufacturing process.
In reporting the company’s Q4 2021 financial results, Revance CEO Mark J. Foley also provided an update on the company’s products, and when speaking about DaxibotulinumtoxinA for Injection said, “We remain focused on getting our neuromodulator approved as soon as possible and look forward to engaging with the agency to facilitate this process.”
Photo 204366604 © Viacheslav Iacobchuk | Dreamstime.com
