Teva Announces Launch of Generic Xeloda® Tablets 150 MG and 500 MG in the United States
07 Mars 2014 - 6:15PM
Business Wire
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announces the
launch of the generic equivalent to Xeloda® (Capecitabine) Tablets,
150 MG and 500 MG, in the United States. Xeloda® is marketed by
Genentech in the United States. Teva was the first to receive
approval on its ANDA from the U.S. Food and Drug Administration on
September 16, 2013 and is launching today per a settlement
agreement.
Xeloda® (Capecitabine) Tablets, 150 MG and 500 MG had annual
sales of approximately $754 million in the United States, according
to IMS data as of December, 2013.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) is a leading
global pharmaceutical company, committed to increasing access to
high-quality healthcare by developing, producing and marketing
affordable generic drugs as well as innovative and specialty
pharmaceuticals and active pharmaceutical ingredients.
Headquartered in Israel, Teva is the world's leading generic drug
maker, with a global product portfolio of more than 1,000 molecules
and a direct presence in approximately 60 countries. Teva's
Specialty Medicines businesses focus on CNS, respiratory oncology,
pain, and women's health therapeutic areas as well as biologics.
Teva currently employs approximately 45,000 people around the world
and reached $20.3 billion in net revenues in 2013.
Safe Harbor Statement under the U.S. Private Securities
Litigation Reform Act of 1995:
This release contains forward-looking statements, which are
based on management’s current beliefs and expectations. Such
statements involve a number of known and unknown risks and
uncertainties that could cause our future results, performance or
achievements to differ significantly from the results, performance
or achievements expressed or implied by such forward-looking
statements. Important factors that could cause or contribute to
such differences include risks relating to: our ability to develop
and commercialize additional pharmaceutical products; competition
for our innovative products, especially Copaxone® (including
competition from orally-administered alternatives, as well as from
potential generic versions); the possibility of material fines,
penalties and other sanctions and other adverse consequences
arising out of our ongoing FCPA investigations and related matters;
our ability to achieve expected results from the research and
development efforts invested in our pipeline of specialty and other
products; our ability to reduce operating expenses to the extent
and during the timeframe intended by our cost reduction program;
our ability to successfully pursue and consummate suitable
acquisitions or licensing opportunities; the extent to which any
manufacturing or quality control problems damage our reputation for
quality production and require costly remediation; our potential
exposure to product liability claims that are not covered by
insurance; increased government scrutiny in both the U.S. and
Europe of our patent settlement agreements; our exposure to
currency fluctuations and restrictions as well as credit risks; the
effectiveness of our patents and other measures to protect the
intellectual property rights of our specialty
medicines; the effects of reforms in healthcare
regulation and pharmaceutical pricing, reimbursement and coverage;
governmental investigations into sales and marketing practices,
particularly for our specialty pharmaceutical products;
uncertainties related to our recent management
changes; the effects of increased leverage and our
resulting reliance on access to the capital markets; any failure to
recruit or retain executives or other key personnel; adverse
effects of political or economical instability, major hostilities
or acts of terrorism on our significant worldwide operations;
interruptions in our supply chain or problems with internal or
third-party information technology systems that adversely affect
our complex manufacturing processes; significant disruptions of our
information technology systems or breaches of our data
security; competition for our generic products, both
from other pharmaceutical companies and as a result of increased
governmental pricing pressures; competition for our specialty
pharmaceutical businesses from companies with greater resources and
capabilities; decreased opportunities to obtain U.S. market
exclusivity for significant new generic products; potential
liability for sales of generic products prior to a final resolution
of outstanding patent litigation; any failures to comply with
complex Medicare and Medicaid reporting and payment obligations;
the impact of continuing consolidation of our distributors and
customers; significant impairment charges relating to intangible
assets and goodwill; the potential for significant tax liabilities;
the effect on our overall effective tax rate of the termination or
expiration of governmental programs or tax benefits, or of a change
in our business; variations in patent laws that may adversely
affect our ability to manufacture our products in the most
efficient manner; environmental risks; and other factors that are
discussed in our Annual Report on Form 20-F for the year ended
December 31, 2013 and in our other filings with the U.S. Securities
and Exchange Commission. Forward-looking statements speak only as
of the date on which they are made and we assume no obligation to
update or revise any forward-looking statement, whether as a result
of new information, future events or otherwise.
Teva Pharmaceutical Industries Ltd.IR:Kevin C.
MannixUnited States215-591-8912orTomer AmitaiIsrael972
(3) 926-7656orRan MeirUnited States215-591-3033orPR:Iris
Beck CodnerIsrael972 (3) 926-7687orDenise BradleyUnited
States215-591-8974
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