Amarin Corporation plc (NASDAQ:AMRN) Stock Trading Halted Today for Scheduled FDA Advisory Committee Review of sNDA Seeking N...
November 14 2019 - 6:59AM
Amarin Corporation plc (NASDAQ:AMRN), a pharmaceutical company
focused on improving cardiovascular health, today announced
that NASDAQ has halted trading of the company's shares. The U.S.
Food and Drug Administration's (FDA) Endocrinologic and Metabolic
Drugs Advisory Committee (EMDAC), as previously scheduled and
announced, is meeting today to openly discuss the company's
supplemental New Drug Application (sNDA) seeking a new indication
for Vascepa® (icosapent ethyl) to reduce the risk of major adverse
cardiovascular events based on the landmark REDUCE-IT®
cardiovascular outcomes study.
The Advisory Committee meeting is scheduled for
8:00 a.m. ET. The briefing materials can be found on the FDA
website at
https://www.fda.gov/advisory-committees/november-14-2019-meeting-endocrinologic-and-metabolic-drugs-advisory-committee-meeting-announcement.
The Prescription Drug User Fee Act (PDUFA) goal date for the FDA’s
review of Vascepa’s supplemental New Drug Application is December
28, 2019.
The EMDAC reviews and evaluates data concerning
the effectiveness and safety of marketed and investigational human
drug products under review at the Division of Metabolism and
Endocrinology Products at FDA and makes appropriate recommendations
to the division. The FDA is not bound by the recommendations of an
advisory committee.
About Amarin
Amarin Corporation plc is a rapidly growing,
innovative pharmaceutical company focused on developing
therapeutics to improve cardiovascular health. Amarin’s product
development program leverages its extensive experience in
polyunsaturated fatty acids and lipid science. Vascepa (icosapent
ethyl) is Amarin's first FDA-approved drug and is available by
prescription in the United States, Lebanon and the United Arab
Emirates. Amarin’s commercial partners are pursuing additional
regulatory approvals for Vascepa in Canada, China and the Middle
East. For more information about Amarin, visit
www.amarincorp.com.
Availability of Other Information About
Amarin
Investors and others should note that Amarin
communicates with its investors and the public using the company
website http://www.amarincorp.com/), the investor relations website
(http://investor.amarincorp.com/), including but not limited to
investor presentations and investor FAQs, Securities and Exchange
Commission filings, press releases, public conference calls and
webcasts. The information that Amarin posts on these channels
and websites could be deemed to be material information. As a
result, Amarin encourages investors, the media, and others
interested in Amarin to review the information that is posted on
these channels, including the investor relations website, on a
regular basis. This list of channels may be updated from time
to time on Amarin’s investor relations website and may include
social media channels. The contents of Amarin’s website or
these channels, or any other website that may be accessed from its
website or these channels, shall not be deemed incorporated by
reference in any filing under the Securities Act of 1933.
Amarin Contact Information
Investor Inquiries:Elisabeth SchwartzInvestor
RelationsAmarin Corporation plcIn U.S.: +1 (908) 719-1315
investor.relations@amarincorp.com
Lee M. SternSolebury TroutIn U.S.: +1 (646) 378-2992
lstern@soleburytrout.com
Media Inquiries:Gwen FisherCorporate
Communications Amarin Corporation plcIn U.S.: +1 (908) 325-0735
pr@amarincorp.com
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