Teva Pharmaceutical Industries Ltd., (NYSE and TASE:TEVA) today
announced approval of generic Tribenzor®1(olmesartan medoxomil,
amlodipine and hydrochlorothiazide) tablets in the U.S. and is in
the final stages of launch preparation. Teva also recently received
approval and launched generic Azor®2 (amlodipine and olmesartan
medoxomil) tablets in the U.S. These products enhance Teva’s
antihypertensive portfolio.
Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets
are a combination of an angiotensin II
receptor blocker, a dihydropyridine calcium channel blocker and
a thiazide diuretic indicated for the treatment of hypertension, to
lower blood pressure.
Amlodipine and olmesartan medoxomil tablets are a
dihydropyridine calcium channel blocker and angiotensin II receptor
blocker combination product indicated for the treatment of
hypertension, alone or with other antihypertensive agents, to lower
blood pressure.
Lowering blood pressure reduces the risk of fatal and nonfatal
cardiovascular events, primarily strokes and myocardial
infarctions. Many patients will require more than one drug to
achieve their blood pressure goals.
Teva is committed to strengthening its generics business through
continued investment in complex, high-quality products. With nearly
600 generic medicines available, Teva has the largest portfolio of
FDA-approved generic products on the market. These products
enhance Teva’s already comprehensive product portfolio.
Teva has over 300 product registrations pending FDA approval 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
generic product.
Tribenzor® had annual sales of approximately $240 million in the
U.S. and Azor® had annual sales of approximately $354.1 million in
the U.S., according to IMS data as of August 2016.
About Olmesartan Medoxomil, Amlodipine and
Hydrochlorothiazide Tablets
Olmesartan medoxomil, amlodipine, hydrochlorothiazide tablets
are indicated for the treatment of hypertension, to lower blood
pressure. Lowering blood pressure reduces the risk of fatal and
nonfatal cardiovascular events, primarily strokes and myocardial
infarctions. These benefits have been seen in controlled trials of
antihypertensive drugs from a wide variety of pharmacologic classes
including the class to which this drug principally belongs. There
are no controlled trials demonstrating risk reduction with
olmesartan medoxomil, amlodipine, hydrochlorothiazide tablets.
Control of high blood pressure should be part of comprehensive
cardiovascular risk management, including, as appropriate, lipid
control, diabetes management, antithrombotic therapy, smoking
cessation, exercise, and limited sodium intake.
Olmesartan medoxomil, amlodipine, hydrochlorothiazide tablets
are not indicated for the initial therapy of hypertension.
Important Safety Information
WARNING: Fetal Toxicity. When pregnancy is detected, discontinue
olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets
as soon as possible. Drugs that act directly on the
renin-angiotensin system can cause injury and death to the
developing fetus.
Because of the hydrochlorothiazide component, olmesartan
medoxomil, amlodipine, and hydrochlorothiazide tablets are
contraindicated in patients with anuria or hypersensitivity to
other sulfonamide-derived drugs. Do not coadminister aliskiren with
olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets
in patients with diabetes.
Other serious adverse reactions that may occur include:
hypotension, particularly in volume- or salt-depleted patients;
increased angina and/or myocardial infarction; impaired renal
function; electrolyte and metabolic imbalances; hypersensitivity
reactions; exacerbation or activation of systemic lupus
erythematosus; acute transient myopia and acute angle-closure
glaucoma; sprue-like enteropathy; and vasodilation. Increased drug
exposure may occur in patients with hepatic impairment. Avoid use
in patients with severely impaired renal or hepatic function.
Most common adverse reactions (incidence ≥ 2%) in a controlled
clinical trial: dizziness, peripheral edema, headache, fatigue,
nasopharyngitis, muscle spasms, nausea, upper respiratory tract
infection, diarrhea, urinary tract infection, and joint
swelling.
For more information, please see accompanying full Prescribing
Information, including Boxed Warning.
About Amlodipine and Olmesartan Medoxomil Tablets
Amlodipine and olmesartan medoxomil tablets are indicated for
the treatment of hypertension, alone or with other antihypertensive
agents, to lower blood pressure. Lowering blood pressure reduces
the risk of fatal and nonfatal cardiovascular events, primarily
strokes and myocardial infarctions. These benefits have been seen
in controlled trials of antihypertensive drugs from a wide variety
of pharmacologic classes including the class to which this drug
principally belongs. There are no controlled trials demonstrating
risk reduction with amlodipine and olmesartan medoxomil
tablets.
Control of high blood pressure should be part of comprehensive
cardiovascular risk management, including, as appropriate, lipid
control, diabetes management, antithrombotic therapy, smoking
cessation, exercise, and limited sodium intake.
Amlodipine and olmesartan medoxomil tablets may also be used as
initial therapy in patients who are likely to need multiple
antihypertensive agents to achieve their blood pressure goals.
Important Safety Information
WARNING: Fetal Toxicity. When pregnancy is detected, discontinue
amlodipine and olmesartan medoxomil tablets as soon as possible.
Drugs that act directly on the renin-angiotensin system can cause
injury and death to the developing fetus.
Do not coadminister aliskiren with in patients with diabetes.
The 10 mg/20 mg amlodipine and olmesartan medoxomil tablets contain
FD&C Yellow No. 5 (tartrazine) which may cause allergic-type
reactions (including bronchial asthma) in certain susceptible
persons and frequently seen in patients who also have aspirin
hypersensitivity.
Other serious adverse reactions that may occur include:
hypotension, particularly in volume- or salt-depleted patients;
vasodilation; increased angina and/or myocardial infarction;
impaired renal function; and sprue-like enteropathy. Increased drug
exposure may occur in patients with hepatic impairment Initial
therapy with amlodipine and olmesartan medoxomil tablets is not
recommended in hepatically impaired patients or patients ≥ 75 years
old.
Most common adverse reaction in a controlled clinical trial
(incidence ≥ 3%): edema.
For more information, please see accompanying full Prescribing
Information, including Boxed Warning.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a
leading global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions used by millions of patients
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 a
world-leading position in innovative treatments for disorders of
the central nervous system, including pain, as well as a strong
portfolio of respiratory products. Teva integrates its generics and
specialty capabilities in its global research and development
division to create new ways of addressing unmet patient needs by
combining drug development capabilities with devices, services and
technologies. Teva's net revenues in 2015 amounted to $19.7
billion. For more information, visit www.tevapharm.com.
Teva's 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 and 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 specialty
products, especially Copaxone® (which faces competition from
orally-administered alternatives and a generic version); our
ability to integrate Allergan plc’s worldwide generic
pharmaceuticals business (“Actavis Generics”) and to realize the
anticipated benefits of the acquisition (and the timing of
realizing such benefits); the fact that following the consummation
of the Actavis Generics acquisition, we are dependent to a much
larger extent than previously on our generic pharmaceutical
business; potential restrictions on our ability to engage in
additional transactions or incur additional indebtedness as a
result of the substantial amount of debt incurred to finance the
Actavis Generics acquisition; the fact that for a period of time
following the Actavis Generics acquisition, we will have
significantly less cash on hand than previously, which could
adversely affect our ability to grow; 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 investments in our
pipeline of specialty and other products; our ability to identify
and successfully bid for suitable acquisition targets or licensing
opportunities, or to consummate and integrate acquisitions; the
extent to which any manufacturing or quality control problems
damage our reputation for quality production and require costly
remediation; 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, confidentiality agreements 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;
competition for our generic products, both from other
pharmaceutical companies and as a result of increased governmental
pricing pressures; governmental investigations into sales and
marketing practices, particularly for our specialty pharmaceutical
products; adverse effects of political or economic 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 specialty pharmaceutical
businesses from companies with greater resources and capabilities;
the impact of continuing consolidation of our distributors and
customers; decreased opportunities to obtain U.S. market
exclusivity for significant new generic products; potential
liability in the U.S., Europe and other markets for sales of
generic products prior to a final resolution of outstanding patent
litigation; our potential exposure to product liability claims that
are not covered by insurance; any failure to recruit or retain key
personnel, or to attract additional executive and managerial
talent; any failures to comply with complex Medicare and Medicaid
reporting and payment obligations; significant impairment charges
relating to intangible assets, goodwill and property, plant and
equipment; the effects of increased leverage and our resulting
reliance on access to the capital markets; potentially significant
increases in 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, 2015 and in our other filings with
the U.S. Securities and Exchange Commission (the "SEC").
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, whether as a
result of new information, future events or otherwise.
1 Tribenzor® is a registered trademark of Daiichi Sankyo
Company.
2 Azor® is a registered trademark of Daiichi Sankyo, Inc.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20161107005524/en/
IR Contacts:Kevin C. Mannix, 215-591-8912United
StatesorRan Meir, 215-591-3033United StatesorTomer
Amitai, 972 (3) 926-7656IsraelorPR Contacts:Iris Beck
Codner, 972 (3) 926-7687IsraelorDenise Bradley,
215-591-8974United StatesorNancy Leone, 215-284-0213United
States
Teva Pharmaceutical Indu... (NYSE:TEVA)
Graphique Historique de l'Action
De Juin 2024 à Juil 2024
Teva Pharmaceutical Indu... (NYSE:TEVA)
Graphique Historique de l'Action
De Juil 2023 à Juil 2024