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|April 28, 2015 3:22 p.m.|
|Teva Launches Generic Abilify® Tablets in the United States|
“Our commitment at Teva is to make affordable, high-quality generic
medicines available to millions of patients every day. We are pleased to
launch generic Aripiprazole tablets and offer a generic treatment for
patients suffering from schizophrenia and bipolar I disorder,” said
Teva remains involved in a patent litigation in the
Schizophrenia is a complex, long-term medical illness that affects a person’s ability to think clearly, manage emotions, make decisions and relate to others. Approximately one percent of adult Americans live with schizophrenia. Schizophrenia is a chronic and disabling brain disorder that affects men and women equally, where people interpret reality abnormally. Symptoms of schizophrenia may include hallucinations, delusions, trouble with thinking and concentration, and lack of motivation.
There are several types of bipolar disorder. Bipolar I disorder is a specific type of bipolar disorder characterized by manic or mixed episodes of feelings of extreme irritability or euphoria. Bipolar I disorder is the most severe form of the illness marked by extreme manic episodes.
Abilify® (aripiprazole) Tablets, marketed by Otsuka
Pharmaceutical, had annual sales of approximately
About Aripiprazole Tablets
Aripiprazole tablets are indicated for:
Important Safety Information
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Aripiprazole is not approved for the treatment of patients with dementia-related psychosis. Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber.
Aripiprazole is contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. Reactions have ranged from pruritus/urticaria to anaphylaxis.
In clinical studies of dementia-related psychosis, there was an increased incidence of cerebrovascular adverse events, including fatalities, in aripiprazole-treated elderly patients.
A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) may occur with administration of antipsychotic drugs, including aripiprazole. Management of NMS should include immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, intensive symptomatic treatment, and medical monitoring.
A syndrome of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs. If signs and symptoms of tardive dyskinesia appear in a patient on aripiprazole, drug discontinuation should be considered if clinically appropriate.
Atypical antipsychotic drugs have been associated with metabolic changes that include hyperglycemia/diabetes mellitus, dyslipidemia, and body weight gain. Monitor glucose regularly in patients with and at risk for diabetes. Clinical monitoring of weight is recommended.
Aripiprazole may cause orthostatic hypotension. Aripiprazole should be used with caution in patients with known cardiovascular disease, cerebrovascular disease, or conditions which would predispose patients to hypotension.
Leukopenia, neutropenia, and agranulocytosis have been reported with antipsychotic agents, including aripiprazole. Patients with a history of a clinically significant low WBC/ANC or drug-induced leukopenia/neutropenia should have their complete blood count monitored frequently during the first few months of therapy. Discontinuation of aripiprazole should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors.
Aripiprazole should be used cautiously in patients with a history of seizures or with conditions that lower the seizure threshold. Conditions that lower the seizure threshold may be more prevalent in a population of 65 years or older.
Aripiprazole, like other antipsychotics, may have the potential to impair judgment, thinking, or motor skills. Patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that therapy with aripiprazole does not affect them adversely.
Disruption of the body’s ability to reduce core body temperature has been attributed to antipsychotic agents. Appropriate care is advised when prescribing aripiprazole for patients who will be experiencing conditions which may contribute to an elevation in core body temperature.
The possibility of a suicide attempt is inherent in schizophrenia and bipolar disorder, and close supervision of high-risk patients should accompany drug therapy. Prescriptions for aripiprazole should be written for the smallest quantity consistent with good patient management in order to reduce the risk of overdose.
Esophageal dysmotility and aspiration have been associated with antipsychotic drug use, including aripiprazole. Aripiprazole and other antipsychotic drugs should be used cautiously in patients at risk for aspiration pneumonia.
In clinical trials, commonly observed adverse reactions (incidence ≥ 5% and at least twice that for placebo) were:
Please see accompanying Full Prescribing Information, including Boxed Warning.
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 innovative products, especially Copaxone®
(including competition from orally-administered alternatives, as well as
from potential purported generic equivalents) and our ability to
migrate users to our 40 mg/mL version; 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 the research and development
efforts invested in our pipeline of specialty and other products; our
ability to reduce operating expenses to the extent and during the
timeframe intended by our cost reduction program; 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
Teva Pharmaceutical Industries Ltd.