Spectrum Pharmaceuticals Announces FDA’s Acceptance of NDA Filing for EOquin® (apaziquone for intravesical instillation)
February 19 2016 - 7:00AM
Business Wire
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology
company with fully integrated commercial and drug development
operations with a primary focus in Hematology and Oncology,
announced that the U.S. Food and Drug Administration (the “FDA”)
has accepted the EOquin® (apaziquone for intravesical instillation)
New Drug Application (NDA) for review. The FDA also indicated that
it plans to hold an advisory committee meeting regarding the NDA.
The FDA has set a target action date under the
Prescription Drug User Fee Act (PDUFA) of December 11,
2016.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a leading biotechnology company
focused on acquiring, developing, and commercializing drug
products, with a primary focus in Hematology and Oncology. Spectrum
currently markets five hematology/oncology drugs, and expects
an FDA decision on another hematology drug in the first
half of 2016. Additionally, Spectrum's pipeline includes three
drugs targeting blockbuster markets in advanced stages of clinical
development. Spectrum's strong track record for in-licensing and
acquiring differentiated drugs, and expertise in clinical
development have generated a robust, diversified, and growing
pipeline of product candidates in advanced-stage Phase 2 and Phase
3 studies. More information on Spectrum is available
at www.sppirx.com.
Forward-looking statement — This press release may contain
forward-looking statements regarding future events and the future
performance of Spectrum Pharmaceuticals that involve risks and
uncertainties that could cause actual results to differ materially.
These statements are based on management's current beliefs and
expectations. These statements include, but are not limited to,
statements that relate to our business and its future, including
certain company milestones, Spectrum's ability to identify,
acquire, develop and commercialize a broad and diverse pipeline of
late-stage clinical and commercial products, leveraging the
expertise of partners and employees around the world to assist us
in the execution of our strategy, and any statements that relate to
the intent, belief, plans or expectations of Spectrum or its
management, or that are not a statement of historical fact. Risks
that could cause actual results to differ include the possibility
that our existing and new drug candidates may not prove safe or
effective, the possibility that our existing and new applications
to the FDA and other regulatory agencies may not receive approval
in a timely manner or at all, the possibility that our existing and
new drug candidates, if approved, may not be more effective, safer
or more cost efficient than competing drugs, the possibility that
our efforts to acquire or in-license and develop additional drug
candidates may fail, our lack of sustained revenue history, our
limited marketing experience, our dependence on third parties for
clinical trials, manufacturing, distribution and quality control
and other risks that are described in further detail in the
Company's reports filed with the Securities and Exchange
Commission. We do not plan to update any such forward-looking
statements and expressly disclaim any duty to update the
information contained in this press release except as required by
law.
SPECTRUM PHARMACEUTICALS, INC.® and EOquin® are registered
trademark of Spectrum Pharmaceuticals, Inc and its affiliates.
REDEFINING CANCER CARE™ and the Spectrum Pharmaceuticals logos are
trademarks owned by Spectrum Pharmaceuticals, Inc. Any other
trademarks are the property of their respective owners.
© 2016 Spectrum Pharmaceuticals, Inc. All Rights Reserved
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Spectrum PharmaceuticalsShiv Kapoor, 702-835-6300Vice President,
Strategic Planning & Investor
RelationsInvestorRelations@sppirx.com
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