Evolus announces progress with DWP-450 regulatory submissions

Evolus

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.

Read Evolus press release

Michael Wonder

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Michael Wonder

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Medicine , US , Dossier