FDA Sets PDUFA Date for Revance DAXI Neuromodulator

Posted By American Med Spa Association, Wednesday, February 12, 2020

The U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for Revance Therapeutics’ DaxibotulinumtoxinA for Injection (DAXI) in the treatment of moderate to severe glabellar (frown) lines. In a press release issued by Revance, the company noted that, in its correspondence, the FDA stated that no potential filing review issues were identified and indicated in the BLA filing communication letter that it is not currently planning to hold an advisory committee meeting to discuss the application. The FDA set a target Prescription Drug User Fee Act (PDUFA) action date of November 25, 2020, for completion of the review.

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