Revance Therapeutics Inc (RVNC): Finally! Revance Provides Update on...

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Wednesday, 05/26/2021 8:10:33 AM

Wednesday, May 26, 2021 8:10:33 AM

Finally!

Revance Provides Update on DaxibotulinumtoxinA for Injection Pre-Approval Inspection

May 26, 2021

NASHVILLE, Tenn.--(BUSINESS WIRE)--May 26, 2021-- Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced that the FDA plans to initiate its pre-approval inspection of the company’s manufacturing facility for DaxibotulinumtoxinA for Injection by the end of June 2021.

In November 2020, Revance received notification from the FDA that the Agency was deferring a decision on the Biologics License Application (BLA) for DaxibotulinumtoxinA for Injection for the treatment of moderate to severe glabellar (frown) lines because the required pre-approval inspection of the company’s manufacturing facility could not be completed due to travel restrictions associated with the COVID-19 pandemic.