FDA Accepts BLA Resubmission for DAXI Injections

Revance Therapeutics announces the FDA has accepted the resubmission for daxibotulinumtoxinA for injection of glabellar lines.

Back in June of 2021, Revance Therapeutics announced the FDA would inmate its pre-approval inspection of the company’s daxibotulinumtoxinA (DAXI, Revance Therapeutics) manufacturing facility.1

Now the botulinum toxin type A injection formulated with a novel peptide excipient has had its Biologics License Application (BLA) resubmission accepted by the FDA for the treatment of moderate to severe glabellar lines.2

The resubmission has been classified as a Class 2 resubmission by the FDA, meaning it is a resubmission that includes any other items, including any item that would warrant presentation to an advisory committee, according to the FDA website.3 The resubmission has a 6-month review period and a reinspection for the company’s manufacturing facitlity. The Prescription Drug User Fee Act (PDUFA) goal date of September 8, 2022. 

References:

  1. Revance provides update on daxibotulinumtoxina for injection pre-approval inspection. BioSpace. May 26, 2021. Accessed June 4, 2021. https://www.biospace.com/article/revance-provides-update-on-daxibotulinumtoxina-for-injection-pre-approval-inspection/
  2. Revance receives FDA acceptance of BLA resubmission for daxibotulinumtoxinA for injection for glabellar lines - RevanceTherapeutics, inc. April 21, 2022. Accessed April 22, 2022. https://investors.revance.com/news-releases/news-release-details/revance-receives-fda-acceptance-bla-resubmission
  3. FDA. Guidance for Industry Classifying Resubmissions in Response to Action Letters. Accessed April 22,2022.