Application Designated as Class 2 by U.S. FDA and Assigned February 2, 2019 PDUFA Date
IRVINE, Calif., Aug. 29, 2018 (GLOBE NEWSWIRE) -- Evolus, Inc. (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 (“FDA”). 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.”
About Evolus, Inc.
Evolus is a company dedicated to aesthetic medicine focused on providing physicians and their patients with expanded choices in aesthetic treatments and procedures. Evolus’ lead candidate DWP-450, also known by the chemical name prabotulinumtoxinA, is a 900 kDa purified botulinum toxin type A complex that was approved by Health Canada for the temporary improvement in the appearance of moderate to severe glabellar lines in adult patients under 65 years of age and is being evaluated for marketing approval in the United States and other areas.
Statements made in this press release that relate to future plans, events, prospects or performance are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including statements containing the words "planned," "expect," "believes," "strategy," "opportunity," "anticipates," "outlook," "designed," and similar words. While these forward-looking statements are based on the current expectations and beliefs of management, such forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors that could cause actual results to differ materially from the expectations expressed in this press release, including the risks and uncertainties disclosed in Evolus’ periodic filings with the Securities and Exchange Commission, including factors described in the section entitled "Risk Factors" in its Annual Report on Form 10-K for the year ended December 31, 2017 and its Quarterly Report on Form 10-Q for the Quarter ended June 30, 2018, as filed with the Securities and Exchange Commission on March 29, 2018 and August 2, 2018, respectively, all of which are available online at www.sec.gov. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, Evolus undertakes no obligation to update or revise any forward-looking statements to reflect new information, changed circumstances or unanticipated events.
Brian Johnston, The Ruth Group
Tel: +1 646-536-7028
Kirsten Thomas, The Ruth Group