April 22, 2022
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FDA approves BLA resubmission for daxibotulinumtoxinA injection
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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.