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Evolus Announces Progress with DWP-450 Regulatory Submissions
May. 16, 2018 09:04AM PST
Longevity InvestingEvolus (NASDAQ:EOLS) a lifestyle aesthetics company focused on delivering advanced aesthetic procedures and treatments to physicians and consumers, today announced updates related to the regulatory progress of its pending Biologics License Application (“BLA”) for DWP-450 (prabotulinumtoxinA) to the U.S. Food and Drug Administration (“FDA”). As quoted in the press release: The FDA issued an Establishment …
Evolus (NASDAQ:EOLS) a lifestyle aesthetics company focused on delivering advanced aesthetic procedures and treatments to physicians and consumers, today announced updates related to the regulatory progress of its pending Biologics License Application (“BLA”) for DWP-450 (prabotulinumtoxinA) to the U.S. Food and Drug Administration (“FDA”).
As quoted in the press release:
The FDA issued an Establishment Inspection Report (“EIR”) to Daewoong Pharmaceutical Co. Ltd. (“Daewoong”) confirming the favorable completion of its pre-approval inspection of Daewoong’s manufacturing facility in South Korea which was purpose built for production of DWP-450.
The DWP-450 manufacturing facility is fully validated by Daewoong under current good manufacturing practice (“cGMP”) requirements, and has capacity expected to meet anticipated product demand. Evolus plans to utilize the Daewoong facility to support commercial production following the anticipated approval of DWP-450.