Teva Announces Launch of Generic Campral® in the United States
22 Mars 2016 - 1:00PM
Business Wire
Teva Pharmaceutical Industries Ltd., (NYSE:TEVA) today announced
the launch of the generic equivalent to CAMPRAL®1 (acamprosate
calcium) delayed-release tablets, 333 mg, in the United States.
Acamprosate calcium delayed-release tablets are used for the
maintenance of abstinence from alcohol in patients with alcohol
dependence who are abstinent at the start of treatment. Treatment
with acamprosate calcium delayed-release tablets helps maintain
abstinence from alcohol only when used as part of a treatment
program that includes counseling and support.
Teva continues its commitment to strengthening its generics
business with continued investment in newer, higher-quality generic
products. With over 375 generic medicines available, Teva has the
largest portfolio of FDA-approved generic products on the
market.
Acamprosate calcium delayed-release tablets had annual sales of
approximately $14 million in the United States, according to IMS
data as of December 2015.
About Acamprosate Calcium Delayed-Release Tablets
Acamprosate calcium delayed-release tablets are indicated for
the maintenance of abstinence from alcohol in patients with alcohol
dependence who are abstinent at treatment initiation. Treatment
with acamprosate calcium delayed-release tablets should be part of
a comprehensive management program that includes psychosocial
support.
The efficacy of acamprosate calcium in promoting abstinence has
not been demonstrated in subjects who have not undergone
detoxification and not achieved alcohol abstinence prior to
beginning acamprosate calcium delayed-release tablets treatment.
The efficacy of acamprosate calcium in promoting abstinence from
alcohol in polysubstance abusers has not been adequately
assessed.
Important Safety Information
Acamprosate calcium is contraindicated in patients who
previously have exhibited hypersensitivity to acamprosate calcium
or any of its components. Acamprosate calcium is contraindicated in
patients with severe renal impairment (creatinine clearance of ≤ 30
mL/min). Treatment with acamprosate calcium in patients with
moderate renal impairment (creatinine clearance of 30 to 50 mL/min)
requires a dose reduction.
Adverse events of a suicidal nature (suicidal ideation, suicide
attempts, completed suicides) and depression were reported in
controlled clinical trials of acamprosate calcium.
Alcohol-dependent patients, including those patients being treated
with acamprosate calcium, should be monitored for the development
of symptoms of depression or suicidal thinking.
Use of acamprosate calcium does not eliminate or diminish
withdrawal symptoms.
Common adverse events that occurred in any acamprosate calcium
treatment group at a rate of 3% or greater and greater than the
placebo group in controlled clinical trials with spontaneously
reported adverse events are: accidental injury, asthenia, pain,
anorexia, diarrhea, flatulence, nausea, anxiety, depression,
dizziness, dry mouth, insomnia, paresthesia, pruritus and
sweating.
For more information, please see the accompanying Full
Prescribing Information.
1 Campral® is a registered trademark of Merck Sante.
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
1,000 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 consummate the acquisition of Allergan plc’s worldwide
generic pharmaceuticals business (“Actavis Generics”) and to
realize the anticipated benefits of such acquisition (and the
timing of realizing such benefits); the fact that following the
consummation of the Actavis Generics acquisition, we will be
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 we will incur to
finance the Actavis Generics acquisition; the fact that for a
period of time following the consummation of 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20160322005622/en/
Teva Pharmaceutical Industries Ltd.IR:United StatesKevin C.
Mannix, 215-591-8912orUnited StatesRan Meir,
215-591-3033orIsraelTomer Amitai, 972 (3)
926-7656orPR:IsraelIris Beck Codner, 972 (3)
926-7687orUnited StatesDenise Bradley, 215-591-8974
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