6 February 2020 - Prescription Drug User Fee Act target action date of 25 November 2020.
Revance Therapeutics including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection (DAXI), today announced that the biologics license application for DAXI in the treatment of moderate to severe glabellar (frown) lines has been accepted for review by the U.S. FDA.
In its correspondence, FDA stated that no potential filing review issues were identified.