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|March 31, 2015 8:30 a.m.|
|Teva Expands Hypertension Line with Launch of Generic Exforge® Tablets in the United States|
Exforge® (amlodipine and valsartan) Tablets are used in the treatment of high blood pressure (hypertension), a chronic condition often without symptoms that is linked to serious health issues such as heart disease and stroke, if not detected early and treated appropriately. With the launch of Amlodipine and Valsartan Tablets, Teva can offer those prescribed Exforge® a generic alternative to help manage their high blood pressure.
Exforge® (amlodipine and valsartan) Tablets had annual sales
About Amlodipine and Valsartan Tablets
Amlodipine and Valsartan Tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Amlodipine and Valsartan Tablets may be used in patients whose blood pressure is not adequately controlled on either monotherapy. Amlodipine and Valsartan Tablets may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.
Important Safety Information
Fetal Toxicity: When pregnancy is detected, discontinue amlodipine and valsartan tablets as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
Do not use Amlodipine and Valsartan Tablets in patients with known hypersensitivity to any component. Do not co-administer aliskiren with Amlodipine and Valsartan Tablets in patients with diabetes.
Excessive hypotension was seen in 0.4% of patients with uncomplicated hypertension treated with Amlodipine and Valsartan Tablets in placebo-controlled studies. Volume depletion should be corrected prior to administration of Amlodipine and Valsartan Tablets. Treatment with Amlodipine and Valsartan Tablets should start under close medical supervision.
Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine, particularly in patients with severe obstructive coronary artery disease.
Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system and by diuretics. Patients whose renal function may depend in part on the activity of the renin-angiotensin system may be at particular risk of developing acute renal failure. Drugs that inhibit the renin-angiotensin system can cause hyperkalemia.
The adverse reactions that occurred in placebo-controlled clinical trials in at least 2% of patients treated with Amlodipine and Valsartan Tablets but at a higher incidence in amlodipine/valsartan patients than placebo included peripheral edema, nasopharyngitis, upper respiratory tract infection, and dizziness.
Please see accompanying Full Prescribing Information, including Boxed Warning.
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 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.