FDA Accepts BLA Resubmission for DAXI Injections

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.