DAXI BLA refiled with FDA for glabellar lines after complete response.- Revance Therapeutics
Revance Therapeutics announced it has resubmitted its Biologics License Application (BLA) to the FDA for DAXI (daxibotulinumtoxinA for Injection) for the treatment of moderate to severe glabellar lines in response to the Complete Response Letter issued by the FDA in October 2021.
Revance Therapeutics announced it has resubmitted its Biologics License Application (BLA) to the FDA for DAXI (daxibotulinumtoxinA for Injection) for the treatment of moderate to severe glabellar lines in response to the Complete Response Letter 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.
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