Posted by Michael Wonder on 26 Nov 2020
FDA defers approval of daxibotulinumtoxinA for injection in glabellar lines due to COVID-19 related travel restrictions impacting manufacturing site inspection
25 November 2020 - Revance Therapeutics today announced that the United States FDA has deferred a decision on the biologics license application for DaxibotulinumtoxinA for Injection, an investigational neuromodulator product for the treatment of moderate to severe glabellar lines.
In a communication received on 24 November 2020, the FDA reiterated that an inspection of the company’s manufacturing facility is required as part of the biologics license application approval process.
