Celgene Notified of ANDA Filing for ABRAXANE®
March 07 2016 - 4:34PM
Business Wire
Celgene Corporation (NASDAQ: CELG, CELGZ) today announced it has
received a Paragraph IV Notice Letter advising that Actavis LLC
submitted an Abbreviated New Drug Application (ANDA) to the U.S.
Food and Drug Administration (FDA) seeking authorization from the
FDA to manufacture and market a generic version of ABRAXANE®
(paclitaxel protein-bound particles for injectable suspension)
(albumin bound) 100 mg/vial in the United States.
The Notice Letter contains Paragraph IV certifications against
certain patents relating to ABRAXANE®. Celgene is assessing the
notice. Celgene intends to vigorously defend its extensive
intellectual property rights relating to ABRAXANE®.
About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an
integrated global biopharmaceutical company engaged primarily in
the discovery, development and commercialization of innovative
therapies for the treatment of cancer and inflammatory diseases
through next-generation solutions in protein homeostasis,
immuno-oncology, epigenetics, immunology and neuro-inflammation.
For more information, please visit www.celgene.com. Follow Celgene
on Social Media: @Celgene, Pinterest, LinkedIn, FaceBook and
YouTube.
About ABRAXANE®
In the U.S., ABRAXANE® for Injectable Suspension (paclitaxel
protein-bound particles for injectable suspension) (albumin-bound)
is indicated for the treatment of breast cancer after failure of
combination chemotherapy for metastatic disease or relapse within
six months of adjuvant chemotherapy. Prior therapy should have
included an anthracycline unless clinically contraindicated.
ABRAXANE® is indicated for the first-line treatment of locally
advanced or metastatic non-small cell lung cancer, in combination
with carboplatin, in patients who are not candidates for curative
surgery or radiation therapy. ABRAXANE® is also indicated for the
first-line treatment of metastatic adenocarcinoma of the pancreas
in combination with gemcitabine.
Forward-Looking Statements
This press release contains forward-looking statements, which
are generally statements that are not historical facts.
Forward-looking statements can be identified by the words
"expects," "anticipates," "believes," "intends," "estimates,"
"plans," "will," “outlook” and similar expressions. Forward-looking
statements are based on management’s current plans, estimates,
assumptions and projections, and speak only as of the date they are
made. We undertake no obligation to update any forward-looking
statement in light of new information or future events, except as
otherwise required by law. Forward-looking statements involve
inherent risks and uncertainties, most of which are difficult to
predict and are generally beyond our control. Actual results or
outcomes may differ materially from those implied by the
forward-looking statements as a result of the impact of a number of
factors, many of which are discussed in more detail in our Annual
Report on Form 10-K and our other reports filed with the Securities
and Exchange Commission.
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version on businesswire.com: http://www.businesswire.com/news/home/20160307006515/en/
Celgene CorporationInvestors:Patrick E. Flanigan III,
908-673-9969Corporate Vice President, Investor
RelationsorMedia:Brian P. Gill, 908-673-9530Vice President,
Corporate Communications
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