• FDA Sets PDUFA Date for Revance DAXI Neuromodulator

    One year ago - By Surgical Aesthetics Magazine

    The United States Food and Drug Administration has accepted the Biologics License Application for Revance Therapeutics' DaxibotulinumtoxinA for Injection in the treatment of moderate to severe glabellar 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 action date of November...
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