16 May 2018 - Evolus receives FDA complete response letter with comments isolated to CMC items.
Evolus today announced updates related to the regulatory progress of its pending biologics license application for DWP-450 (prabotulinumtoxinA) to the U.S. FDA.
The FDA issued an Establishment Inspection Report to Daewoong Pharmaceutical confirming the favourable completion of its pre-approval inspection of Daewoong’s manufacturing facility in South Korea which was purpose built for production of DWP-450.