Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today
announced the launch of an authorized generic of Flector®1 Patch,
1.3 %, in the U.S.
Diclofenac Epolamine Topical Patch, 1.3%, a nonsteroidal
anti-inflammatory drug (NSAID), is indicated for the topical
treatment of acute pain due to minor strains, sprains and
contusions.
“The launch of our authorized generic of Flector® Patch in the
U.S. is an important addition to Teva’s portfolio of over 40
generic pain management medicines,” said Brendan O’Grady, EVP and
Head of North America Commercial.
With nearly 500 generic medicines available, Teva has the
largest portfolio of FDA-approved generic products on the market
and holds the leading position in first-to-file opportunities, with
over 100 pending first-to-files in the U.S. Currently, one in eight
generic prescriptions dispensed in the U.S. is filled with a Teva
generic product. With the launch of Diclofenac Epolamine Topical
Patch, 1.3%, Teva now has over 16 medicines in the Analgesics and
Antipyretics, Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
therapeutic area in the U.S.
Flector® Patch had annual sales of $123 million in the U.S.,
according to IQVIA data as of December 2018.
About Diclofenac Epolamine Topical Patch, 1.3%
Diclofenac Epolamine Topical Patch, 1.3% is indicated for the
topical treatment of acute pain due to minor strains, sprains, and
contusions.
IMPORTANT SAFETY INFORMATION
WARNING: NSAIDs cause an increased risk of serious
cardiovascular thrombotic events, including myocardial infarction
and stroke, which can be fatal. This risk may occur early in
treatment and may increase with duration of use. Diclofenac
Epolamine Topical Patch, 1.3% is contraindicated in the setting of
coronary artery bypass graft (CABG) surgery. NSAIDs cause an
increased risk of serious gastrointestinal (GI) adverse events
including bleeding, ulceration, and perforation of the stomach or
intestines, which can be fatal. These events can occur at any time
during use and without warning symptoms. Elderly patients and
patients with a prior history of peptic ulcer disease and/or GI
bleeding are at greater risk for serious GI events.
Diclofenac Epolamine Topical Patch, 1.3% is contraindicated in
patients with known hypersensitivity (e.g., anaphylactic reactions
and serious skin reactions) to diclofenac or any components of the
drug product. Diclofenac Epolamine Topical Patch, 1.3% is
contraindicated in patients with a history of asthma, urticaria, or
other allergic-type reactions after taking aspirin or other NSAIDs.
Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been
reported in such patients. Diclofenac Epolamine Topical Patch, 1.3%
is contraindicated for use on non-intact or damaged skin resulting
from any etiology, including, exudative dermatitis, eczema,
infected lesions, burns, or wounds.
The following serious adverse reactions are also associated with
the use of NSAIDs, including diclofenac: hepatotoxicity; new onset
or worsening of hypertension; heart failure; fluid retention;
edema; renal toxicity; hyperkalemia; anaphylactic reactions;
exacerbation of aspirin-sensitive asthma; serious skin reactions,
such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and
toxic epidermal necrolysis (TEN); premature closure of fetal ductus
arteriosus; anemia; and increased risk of bleeding events.
Concomitant use of oral and topical NSAIDs may result in a higher
rate of hemorrhage, and more frequent abnormal creatinine, urea and
hemoglobin.
In controlled clinical trials, the most common adverse reactions
for Diclofenac Epolamine Topical Patch, 1.3% and placebo patch were
application site reactions, occurring in 11% and 12% of patients,
respectively. Gastrointestinal disorders were reported for
Diclofenac Epolamine Topical Patch, 1.3% and placebo patch in 9%
and 6% of patients, respectively.
For more information, please see accompanying Full Prescribing
Information, including the Boxed Warning. A copy may be requested
from Teva US Medical Information at 888-TEVA-USA (888-838-2872),
druginfo@tevapharm.com, or Teva’s Public Relations or Investor
Relations contacts.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a
global leader in generic medicines, with innovative treatments in
select areas, including CNS, pain and respiratory. We deliver
high-quality generic products and medicines in nearly every
therapeutic area to address unmet patient needs. We have an
established presence in generics, specialty, OTC and API, building
on more than a century-old legacy, with a fully integrated R&D
function, strong operational base and global infrastructure and
scale. We strive to act in a socially and environmentally
responsible way. Headquartered in Israel, with production and
research facilities around the globe, we employ 45,000
professionals, committed to improving the lives of millions of
patients. Learn more at www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
regarding the launch and potential benefits of the authorized
generic of Flector® Patch, 1.3 %, which are based on management’s
current beliefs and expectations and are subject to substantial
risks and uncertainties, both known and unknown, that could cause
our future results, performance or achievements to differ
significantly from that expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include risks relating to:
- commercial success of the authorized
generic version of Flector® Patch;
- our ability to successfully compete in
the marketplace, including: that we are substantially dependent on
our generic products; competition for our specialty products,
especially COPAXONE®, our leading medicine, which faces competition
from existing and potential additional generic versions and
orally-administered alternatives; the uncertainty of commercial
success of AJOVY® or AUSTEDO®; competition from companies with
greater resources and capabilities; efforts of pharmaceutical
companies to limit the use of generics, including through
legislation and regulations; consolidation of our customer base and
commercial alliances among our customers; the increase in the
number of competitors targeting generic opportunities and seeking
U.S. market exclusivity for generic versions of significant
products; price erosion relating to our products, both from
competing products and increased regulation; delays in launches of
new products and our ability to achieve expected results from
investments in our product pipeline; our ability to take advantage
of high-value opportunities; the difficulty and expense of
obtaining licenses to proprietary technologies; and the
effectiveness of our patents and other measures to protect our
intellectual property rights;
- our substantial indebtedness, which may
limit our ability to incur additional indebtedness, engage in
additional transactions or make new investments, may result in a
further downgrade of our credit ratings; and our inability to raise
debt or borrow funds in amounts or on terms that are favorable to
us;
- our business and operations in general,
including: failure to effectively execute our restructuring plan
announced in December 2017; uncertainties related to, and failure
to achieve, the potential benefits and success of our new senior
management team and organizational structure; harm to our pipeline
of future products due to the ongoing review of our R&D
programs; our ability to develop and commercialize additional
pharmaceutical products; potential additional adverse consequences
following our resolution with the U.S. government of our FCPA
investigation; compliance with sanctions and other trade control
laws; manufacturing or quality control problems, which may damage
our reputation for quality production and require costly
remediation; interruptions in our supply chain; disruptions of our
or third party information technology systems or breaches of our
data security; the failure to recruit or retain key personnel;
variations in intellectual property laws that may adversely affect
our ability to manufacture our products; challenges associated with
conducting business globally, including adverse effects of
political or economic instability, major hostilities or terrorism;
significant sales to a limited number of customers in our U.S.
market; our ability to successfully bid for suitable acquisition
targets or licensing opportunities, or to consummate and integrate
acquisitions; and our prospects and opportunities for growth if we
sell assets ;
- compliance, regulatory and litigation
matters, including: costs and delays resulting from the extensive
governmental regulation to which we are subject; the effects of
reforms in healthcare regulation and reductions in pharmaceutical
pricing, reimbursement and coverage; governmental investigations
into selling and marketing practices; potential liability for
patent infringement; product liability claims; increased government
scrutiny of our patent settlement agreements; failure to comply
with complex Medicare and Medicaid reporting and payment
obligations; and environmental risks;
- other financial and economic risks,
including: our exposure to currency fluctuations and restrictions
as well as credit risks; potential impairments of our intangible
assets; potential significant increases in tax liabilities; and 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;
and other factors discussed in our Annual Report on Form 10-K
for the year ended December 31, 2018, including the sections
thereof captioned "Risk Factors." 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 statements or
other information contained herein, whether as a result of new
information.
1 Flector® is a registered trademark of IBSA Institute
Biochimique SA, licensed by Alpharma Pharmaceuticals LLC, a
subsidiary of Pfizer Inc.
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version on businesswire.com: https://www.businesswire.com/news/home/20190301005551/en/
IR ContactsUnited StatesKevin C. Mannix, (215)
591-8912IsraelRan Meir, 972 (3) 926-7516
PR ContactsUnited StatesKelley Dougherty, (973)
658-0237IsraelYonatan Beker, 972 (54) 888 5898
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