Posted by Michael Wonder on 29 Aug 2018
Evolus receives acceptance of FDA BLA resubmission for DWP-450
29 August 2018 - Application designated as Class 2 by U.S. FDA and assigned 2 February 2019 PDUFA date.
Evolus today announced the acceptance of its resubmission of its biologics license application for its lead product candidate, prabotulinumtoxinA (DWP-450), by the U.S. FDA.
David Moatazedi, President and Chief Executive Officer of Evolus, stated, “We have worked diligently to advance our regulatory submission for DWP-450. With this notice from the FDA we remain on track to launch commercially in the U.S. in Spring 2019. We look forward to providing an update on the status of our application per our PDUFA date of February 2, 2019 and to continuing the development of our sales and marketing strategy for DWP-450.”
