Evolus Receives Acceptance of FDA BLA Resubmission for DWP-450
August 29 2018 - 8:01AM
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.
Forward-Looking Statements
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.
Evolus Contacts:
Investor Contact:Brian Johnston, The Ruth Group Tel: +1
646-536-7028Email: IR@Evolus.com
Media:Kirsten Thomas, The Ruth GroupTel: +1-508-280-6592Email:
kthomas@theruthgroup.com
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