Posted by Michael Wonder on 18 Oct 2021
Revance provides regulatory update on daxibotulinumtoxinA for injection for the treatment of moderate to severe glabellar (frown) lines
15 October 2021 - Revance Therapeutics today announced that the US FDA has issued a complete response letter regarding the biologics license application for daxibotulinumtoxinA for injection, for the treatment of moderate to severe glabellar (frown) lines.
In a communication received on 15 October 2021, the FDA has determined it is unable to approve the biologics license application in its present form, and indicated that there are deficiencies related to the FDA’s onsite inspection at Revance’s manufacturing facility.
