India Pharma Outlook Team | Monday, 25 April 2022
Revance Therapeutics, Inc., a biotechnology company focused on innovative aesthetic and therapeutic offerings, announced that the US Food and Drug Administration (FDA) has accepted its Biologics License
Application (BLA) resubmission for DaxibotulinumtoxinA for injection for the treatment of moderate to severe glabellar lines. The FDA designated the BLA as a Class 2 resubmission, which has a six-month review period and includes a required reinspection of the company’s manufacturing facility.
Revance was provided a Prescription Drug User Fee Act (PDUFA) goal date of September 8, 2022. Revance is a commercial stage biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation, long-acting neuromodulator product, DaxibotulinumtoxinA for injection.
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