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Evolus Receives Acceptance of FDA BLA Resubmission for DWP-450
Aug. 29, 2018 12:19PM PST
Longevity InvestingEvolus (NASDAQ:EOLS), a company dedicated to aesthetic medicine, today announced the acceptance of its resubmission of its Biologics License Application for its lead product candidate, prabotulinumtoxinA (DWP-450), by the U.S. Food and Drug Administration. As quoted in the press release: The FDA considered the resubmission a Class 2 response and has assigned a February 2, …
Evolus (NASDAQ:EOLS), a company dedicated to aesthetic medicine, today announced the acceptance of its resubmission of its Biologics License Application for its lead product candidate, prabotulinumtoxinA (DWP-450), by the U.S. Food and Drug Administration.
As quoted in the press release:
The FDA considered the resubmission a Class 2 response and has assigned a February 2, 2019 action date per the Prescription Drug User Fee Act (PDUFA).
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.”