Teva Announces Launch of Generic Vytorin® in the United States
27 April 2017 - 6:09AM
Business Wire
Teva Pharmaceutical Industries Ltd., (NYSE and TASE:TEVA) today
announced the launch of generic Vytorin®1 (ezetimibe and
simvastatin) tablets in the U.S.
Ezetimibe and simvastatin tablets are a prescription medicine
that contains two (2) cholesterol lowering medicines, ezetimibe and
simvastatin, which are used along with diet to:
- Lower the level of “bad” cholesterol
(low density lipoprotein cholesterol or LDL)
- Increase the level of “good”
cholesterol (high density lipoprotein cholesterol or HDL)
- Lower the level of fat in blood
(triglycerides)
Ezetimibe and simvastatin tablets further enhance Teva’s statin
portfolio. With nearly 600 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 six generic prescriptions dispensed in the U.S.
is filled with a Teva product.
Vytorin® had annual sales of approximately $678 million in the
U.S. according to IMS data as of February 2017.
About Ezetimibe and Simvastatin TabletsTherapy with
lipid-altering agents should be only one component of multiple risk
factor intervention in individuals at significantly increased risk
for atherosclerotic vascular disease due to hypercholesterolemia.
Drug therapy is indicated as an adjunct to diet when the response
to a diet restricted in saturated fat and cholesterol and other
nonpharmacologic measures alone has been inadequate.
Ezetimibe and simvastatin tablets are indicated for the
reduction of elevated total cholesterol (total-C), low-density
lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B),
triglycerides (TG), and non-high-density lipoprotein cholesterol
(non-HDL-C), and to increase high-density lipoprotein cholesterol
(HDL-C) in patients with primary (heterozygous familial and
non-familial) hyperlipidemia or mixed hyperlipidemia.
Ezetimibe and simvastatin tablets are indicated for the
reduction of elevated total-C and LDL-C in patients with homozygous
familial hypercholesterolemia, as an adjunct to other
lipid-lowering treatments (e.g., LDL apheresis) or if such
treatments are unavailable.
Limitations of Use: No incremental benefit of ezetimibe and
simvastatin tablets on cardiovascular morbidity and mortality over
and above that demonstrated for simvastatin has been established.
Ezetimibe and simvastatin tablets have not been studied in
Fredrickson type I, III, IV, and V dyslipidemias.
Important Safety
InformationEzetimibe and simvastatin tablets are
contraindicated in the following conditions:
- Concomitant administration of strong
CYP3A4 inhibitors.
- Concomitant administration of
gemfibrozil, cyclosporine, or danazol.
- Hypersensitivity to any component of
this medication.
- Active liver disease or unexplained
persistent elevations in hepatic transaminase levels.
- Women who are pregnant or may become
pregnant. Ezetimibe and simvastatin should be administered to women
of childbearing age only when such patients are highly unlikely to
conceive.
- Nursing mothers.
Simvastatin occasionally causes myopathy manifested as muscle
pain, tenderness or weakness with creatine kinase above ten times
the upper limit of normal (ULN). Myopathy sometimes takes the form
of rhabdomyolysis with or without acute renal failure secondary to
myoglobinuria, and rare fatalities have occurred. The risk of
myopathy is increased by high levels of statin activity in plasma.
Predisposing factors for myopathy include advanced age (greater
than or equal to 65 years), female gender, uncontrolled
hypothyroidism, and renal impairment. The risk of myopathy,
including rhabdomyolysis, is dose related.
Persistent elevations in hepatic transaminase levels can occur.
Active liver diseases or unexplained persistent transaminase
elevations are contraindications to the use of ezetimibe and
simvastatin. Increases in HbA1c and fasting serum glucose levels
have been reported with HMG-CoA reductase inhibitors, including
simvastatin. Common (incidence greater than or equal to 2% and
greater than placebo) adverse reactions in clinical trials:
headache, increased ALT, myalgia, upper respiratory tract
infection, and diarrhea.
For more information, please see accompanying
Full Prescribing Information.
About TevaTeva Pharmaceutical Industries Ltd. (NYSE and
TASE: TEVA) is a leading global pharmaceutical company that
delivers high-quality, patient-centric healthcare solutions used by
approximately 200 million patients in 100 markets every day.
Headquartered in Israel, Teva is the world’s largest generic
medicines producer, leveraging its portfolio of more than 1,800
molecules to produce a wide range of generic products in nearly
every therapeutic area. In specialty medicines, Teva has the
world-leading innovative treatment for multiple sclerosis as well
as late-stage development programs for other disorders of the
central nervous system, including movement disorders, migraine,
pain and neurodegenerative conditions, as well as a broad portfolio
of respiratory products. Teva is leveraging its generics and
specialty capabilities in order to seek new ways of addressing
unmet patient needs by combining drug development with devices,
services and technologies. Teva's net revenues in 2016 were $21.9
billion. For more information, visit www.tevapharm.com.
Cautionary Note Regarding Forward-Looking StatementsThis
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 Teva's generic
version of Vytorin®, 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 Teva's generic
version of Vytorin®;
- our generics medicines business,
including: that we are substantially more dependent on this
business, with its significant attendant risks, following our
acquisition of Allergan plc’s worldwide generic pharmaceuticals
business (“Actavis Generics”); our ability to realize the
anticipated benefits of the acquisition (and any delay in realizing
those benefits) or difficulties in integrating Actavis Generics;
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
generic products, both from competing products and as a result of
increased governmental pricing pressures; and our ability to take
advantage of high-value biosimilar opportunities;
- our business and operations in general,
including: our ability to develop and commercialize additional
pharmaceutical products; 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,
including those who joined us as part of the Actavis Generics
acquisition; the restructuring of our manufacturing network,
including potential related labor unrest; the impact of continuing
consolidation of our distributors and customers; and variations in
patent laws that may adversely affect our ability to manufacture
our products;
- 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; potential additional adverse
consequences following our resolution with the U.S. government of
our FCPA investigation; governmental investigations into sales and
marketing practices; potential liability for sales of generic
products prior to a final resolution of outstanding patent
litigation; 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.
and other factors discussed in our Annual Report on Form 20-F
for the year ended December 31, 2016 (“Annual Report”),
including in the section captioned "Risk Factors," and in our other
filings with the U.S. Securities and Exchange Commission which
are available at www.sec.gov and www.tevapharm.com. 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, future events or otherwise. You are
cautioned not to put undue reliance on these forward looking
statements. .
1 Vytorin® is a registered trademark of Merck & Co.,
Inc.
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version on businesswire.com: http://www.businesswire.com/news/home/20170426006674/en/
Teva Pharmaceutical Industries Ltd.IR Contacts:United
StatesKevin C. Mannix, 215-591-8912orRan Meir,
215-591-3033orIsraelTomer Amitai, 972 (3) 926-7656orPR
Contacts:IsraelIris Beck Codner, 972 (3) 926-7246orUnited
StatesDenise Bradley, 215-591-8974orNancy Leone,
215-284-0213
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