Celgene Notified of ANDA Filing for POMALYST®
April 03 2017 - 6:00PM
Business Wire
Celgene Corporation (NASDAQ:CELG) has received a Paragraph IV
Notice Letter advising that Teva Pharmaceuticals USA, Inc.
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 POMALYST®
(pomalidomide) 1 mg, 2 mg, 3 mg and 4 mg in the United States.
The Notice Letter contains Paragraph IV certifications against
certain patents related to POMALYST®. Celgene is assessing the
notice. Celgene intends to vigorously defend its extensive
intellectual property rights related to POMALYST®.
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 POMALYST®
In the U.S., POMALYST® (pomalidomide) is indicated for patients
with multiple myeloma who have received at least two prior
therapies including lenalidomide and a proteasome inhibitor and
have demonstrated disease progression on or within 60 days of
completion of the last therapy.
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/20170403006638/en/
Celgene CorporationPatrick E. Flanigan III,
908-673-9969Corporate VP, Investor RelationsorCelgene
CorporationBrian Gill, 908-673-9530VP, Corporate Communications
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