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Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today
announced the launch of a generic version of Tracleer®1
(bosentan) tablets, 62.5 mg and 125 mg, in the U.S.
Bosentan Tablets are an endothelin receptor antagonist indicated for the
treatment of pulmonary arterial hypertension (PAH, WHO Group 1) in
adults to improve exercise ability and to decrease worsening of the
condition. PAH is high blood pressure in the blood vessels of the lungs.
Due to the risks of liver damage, and serious birth defects, Bosentan
Tablets are available only through a restricted distribution program
called the Bosentan REMS Program.
“The launch of Bosentan Tablets in the U.S. is an important addition to
Teva’s generics portfolio,” said Brendan O’Grady, EVP and Head of North
America Commercial. “The exact cause of PAH is unknown with no known
cure.2 We are proud to offer another generic treatment option
to patients living with this chronic condition.”
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 nine generic prescriptions
dispensed in the U.S. is filled with a Teva generic product.
About Bosentan Tablets
Bosentan Tablets are indicated for the treatment of pulmonary arterial
hypertension (PAH) (WHO Group 1) in adults to improve exercise ability
and to decrease clinical worsening. Studies establishing effectiveness
included predominantly patients with WHO Functional Class II-IV symptoms
and etiologies of idiopathic or heritable PAH (60%), PAH associated with
connective tissue diseases (21%), and PAH associated with congenital
heart disease with left-to-right shunts (18%).
Important Safety Information
WARNING: Risks of
Hepatotoxicity and Embryo-Fetal Toxicity.
Because of the risks of hepatotoxicity and birth defects, Bosentan
Tablets are available only through a restricted program called the
Bosentan REMS Program. Elevations of liver aminotransferases (ALT, AST)
and liver failure have been reported with bosentan.
likely to cause major birth defects if used by pregnant females based on
Therefore, pregnancy must be excluded before the
start of treatment with Bosentan Tablets.
Use of bosentan is contraindicated in females who are or may become
pregnant. To prevent pregnancy, females of reproductive potential must
use two reliable forms of contraception during treatment and for one
month after stopping bosentan. Coadministration of cyclosporine A and
bosentan resulted in markedly increased plasma concentrations of
bosentan. Therefore, concomitant use of bosentan and cyclosporine A is
contraindicated. An increased risk of liver enzyme elevations was
observed in patients receiving glyburide concomitantly with bosentan.
Therefore coadministration of glyburide and bosentan is contraindicated.
Bosentan is contraindicated in patients who are hypersensitive to
bosentan or any component of the product. Observed reactions include
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS),
anaphylaxis, rash, and angioedema.
Peripheral edema is a known clinical consequence of PAH and worsening
PAH and is also a known effect of bosentan and other endothelin receptor
antagonists. In PAH clinical trials with bosentan, combined adverse
events of fluid retention or edema were reported in 1.7%
(placebo-corrected) of patients. In addition, there have been numerous
postmarketing reports of fluid retention in patients with pulmonary
hypertension occurring within weeks after starting bosentan. Patients
required intervention with a diuretic, fluid management, or
hospitalization for decompensating heart failure. Pulmonary edema could
be the possibility of associated pulmonary veno-occlusive disease.
Decreased sperm counts have been observed in patients receiving
bosentan. Preclinical data also suggest that bosentan, similar to other
endothelin receptor antagonists, may have an adverse effect on
spermatogenesis. Treatment with bosentan can cause a dose-related
decrease in hemoglobin and hematocrit. There have been postmarketing
reports of decreases in hemoglobin concentration and hematocrit that
have resulted in anemia requiring transfusion.
In clinical trials, the most common adverse reactions (greater than or
equal to 3% and greater than placebo) were respiratory tract infection,
headache, edema, chest pain, syncope, flushing, hypotension, sinusitis,
arthralgia, abnormal serum aminotransferases, palpitations, and anemia.
Respiratory tract infection and anemia occurred at a rate greater than
or equal to 3% more than placebo.
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
or Teva’s Public Relations or Investor Relations contacts.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been
developing and producing medicines to improve people’s lives for more
than a century. We are a global leader in generic and specialty
medicines with a portfolio consisting of over 35,000 products in nearly
every therapeutic area. Around 200 million people around the world take
a Teva medicine every day, and are served by one of the largest and most
complex supply chains in the pharmaceutical industry. Along with our
established presence in generics, we have significant innovative
research and operations supporting our growing portfolio of specialty
and biopharmaceutical products. 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 generic version of
(bosentan) tablets 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:
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 Tracleer® is a registered trademark of Actelion
View source version on businesswire.com:
Kevin C. Mannix (215)
591-8912IsraelRan Meir 972 (3) 926-7516
Kelley Dougherty (973)
658-0237IsraelYonatan Beker 972 (54) 888 5898
Source: Teva Pharmaceutical Industries Ltd.