FDA approves BLA resubmission for daxibotulinumtoxinA injection

Revance Therapeutics announced the FDA has accepted its Biologics License Application resubmission for daxibotulinumtoxinA for injection for the treatment of moderate to severe glabellar lines, according to a company press release.
The FDA designated the company’s biologics license application as a class 2 resubmission with a six-month review period and a required reinspection of its manufacturing facility.
The company was provided a prescription drug user fee act goal date of September 8, 2022, according to the release.

Revance Therapeutics announced the FDA has accepted its Biologics License Application resubmission for daxibotulinumtoxinA for injection for the treatment of moderate to severe glabellar lines, according to a company press release.
The FDA designated the company’s biologics license application as a class 2 resubmission with a six-month review period and a required reinspection of its manufacturing facility.
The company was provided a prescription drug user fee act goal date of September 8, 2022, according to the release.