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.