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|April 26, 2017 4:09 p.m.|
|Teva Announces Launch of Generic Vytorin® in the United States|
Ezetimibe and simvastatin tablets are a prescription medicine that contains two (2) cholesterol lowering medicines, ezetimibe and simvastatin, which are used along with diet to:
Ezetimibe and simvastatin tablets further enhance Teva’s statin
portfolio. With nearly 600 generic medicines available, Teva has the
largest portfolio of
Vytorin® had annual sales of approximately
About Ezetimibe and Simvastatin Tablets
Ezetimibe and simvastatin tablets are indicated for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and non-high-density lipoprotein cholesterol (non-HDL-C), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia.
Ezetimibe and simvastatin tablets are indicated for the reduction of elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.
Limitations of Use: No incremental benefit of ezetimibe and simvastatin tablets on cardiovascular morbidity and mortality over and above that demonstrated for simvastatin has been established. Ezetimibe and simvastatin tablets have not been studied in Fredrickson type I, III, IV, and V dyslipidemias.
Important Safety Information
Simvastatin occasionally causes myopathy manifested as muscle pain, tenderness or weakness with creatine kinase above ten times the upper limit of normal (ULN). Myopathy sometimes takes the form of rhabdomyolysis with or without acute renal failure secondary to myoglobinuria, and rare fatalities have occurred. The risk of myopathy is increased by high levels of statin activity in plasma. Predisposing factors for myopathy include advanced age (greater than or equal to 65 years), female gender, uncontrolled hypothyroidism, and renal impairment. The risk of myopathy, including rhabdomyolysis, is dose related.
Persistent elevations in hepatic transaminase levels can occur. Active liver diseases or unexplained persistent transaminase elevations are contraindications to the use of ezetimibe and simvastatin. Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including simvastatin. Common (incidence greater than or equal to 2% and greater than placebo) adverse reactions in clinical trials: headache, increased ALT, myalgia, upper respiratory tract infection, and diarrhea.
For more information, please see accompanying Full Prescribing Information.
Cautionary Note Regarding Forward-Looking Statements
and other factors discussed in our Annual Report on Form 20-F for the year ended December 31, 2016 (“Annual Report”), including in the section captioned "Risk Factors," and in our other filings with the U.S. Securities and Exchange Commission which are available at www.sec.gov and www.tevapharm.com. 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 contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward looking statements. .
1 Vytorin® is a registered trademark of
Teva Pharmaceutical Industries Ltd.