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|March 22, 2016 8:00 a.m.|
|Teva Announces Launch of Generic Campral® in the United States|
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
Acamprosate calcium delayed-release tablets had annual sales of
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.
Teva's Safe Harbor Statement under the
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
Teva Pharmaceutical Industries Ltd.