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|July 01, 2015 8:31 a.m.|
|Teva Launches Generic Aggrenox® Capsules in the United States|
“The National Institutes of Health estimates 185,000 Americans are at risk of another stroke within 5 years of a previous stroke. Teva recognizes the devastating impact of a stroke and is pleased to launch generic aspirin and extended-release dipyridamole capsules as a treatment option for at-risk stroke patients,” said Brendan O’Grady, President and CEO, North America Generic Medicines for Teva. “Being able to make affordable, high-quality generic medicines available to millions of patients every day is our commitment at Teva.”
A stroke is caused when there is an interruption to the flow of oxygen rich blood to the brain. Without oxygen, brain cells can become damaged and die. Sudden bleeding in the brain can also cause a stroke if it damages brain cells. A stroke can result in brain damage, long-term disability, or even death.
On average, one American dies from stroke every four minutes. As the fifth leading cause of death in America, every year, more than 795,000 people have a stroke, and 25% have had a previous stroke. About 130,000 people will die as the result of a stroke each year.
Aggrenox® (aspirin/extended-release dipyridamole) capsules
had annual sales of approximately
About Aspirin and Extended-release Dipyridamole Capsules
Aspirin and extended-release dipyridamole capsules are indicated to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis.
Important Safety Information
Aspirin and extended-release dipyridamole capsules are contraindicated in patients with known hypersensitivity to any of the product components. Aspirin is contraindicated in patients with known allergy to nonsteroidal anti-inflammatory drug products and in patients with the syndrome of asthma, rhinitis, and nasal polyps. Aspirin may cause severe urticaria, angioedema or bronchospasm. Do not use aspirin in children or teenagers with viral infections because of the risk of Reye syndrome.
Aspirin and extended-release dipyridamole capsules increase the risk of bleeding. Avoid aspirin in patients with severe renal failure. Elevations of hepatic enzymes and hepatic failure have been reported in association with dipyridamole administration.
Because aspirin and extended-release dipyridamole capsules contain aspirin, aspirin and extended-release dipyridamole capsules can cause fetal harm when administered to a pregnant woman.
Dipyridamole has a vasodilatory effect. Chest pain may be precipitated or aggravated in patients with underlying coronary artery disease who are receiving dipyridamole. For stroke or TIA patients for whom aspirin is indicated to prevent recurrent myocardial infarction (MI) or angina pectoris, the aspirin in this product may not provide adequate treatment for the cardiac indications. Dipyridamole produces peripheral vasodilation, which can exacerbate pre-existing hypotension.
Aspirin and extended-release dipyridamole capsules are not interchangeable with the individual components of aspirin and dipyridamole tablets.
The most frequently reported adverse reactions (>10% and greater than placebo) in a controlled clinical study were headache, dyspepsia, abdominal pain, nausea, and diarrhea.
Please see accompanying Full Prescribing Information.
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.