Original Article JERUSALEM--(BUSINESS WIRE)--Jun. 12, 2017-- Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today announced the launch of generic Zetia®1 (ezetimibe) tablets, 10 mg, in the U.S. Ezetimibe is a prescription medicine used to lower levels of total cholesterol and low-density lipoprotein (LDL) cholesterol in the blood. Ezetimibe tablets are for patients who cannot control their cholesterol levels by diet and exercise alone. It can be used by itself or with other medicines to treat high cholesterol. Ezetimibe tablets work to reduce the amount of cholesterol the body absorbs. According to the American Heart Association (AHA), approximately one third of American adults (73.5 million people) have high LDL cholesterol.2 Fewer than 50% of these individuals are being treated for high LDL cholesterol, and approximately 30% have their condition under control.2,3 People with high blood cholesterol are at risk of heart disease, which is the leading cause of death in the United States. “Despite advances in the treatment of high cholesterol in recent years, many people are still living with active disease and are in need of additional generic therapeutic options,” said Dipankar Bhattacharjee, Teva’s President and CEO, Global Generic Medicines. “We are excited to add another strong generic to our U.S. portfolio and see potential to build on its success by leveraging our expertise in the cardiovascular area.” Teva is committed to strengthening its generics business through continued investment in complex, high-quality products. With nearly 600 generic medicines available, Teva has the largest portfolio of FDA-approved generic products on the market and holds the leading position in first-to-file opportunities, with over 100 pending first-to-files in the U.S. Currently, one in six generic prescriptions dispensed in the U.S. is filled with a Teva product. Ezetimibe tablets had annual sales of approximately $2.7 billion in the U.S., according to IMS data as of March 2017. About Ezetimibe Tablets Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Ezetimibe tablets, administered alone, are indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and non-high-density lipoprotein cholesterol (non-HDL-C) in patients with primary (heterozygous familial and non-familial) hyperlipidemia. Ezetimibe tablets, administered in combination with a 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor (statin), are indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia. Ezetimibe tablets, administered in combination with fenofibrate, are indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, Apo B, and non-HDL-C in adult patients with mixed hyperlipidemia. The combination of ezetimibe and atorvastatin or simvastatin is indicated for the reduction of elevated total-C and LDL-C levels in patients with HoFH, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable. Ezetimibe tablets are indicated as adjunctive therapy to diet for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolemia. Limitations of Use: The effect of ezetimibe tablets on cardiovascular morbidity and mortality has not been determined. Ezetimibe tablets have not been studied in Fredrickson Type I, III, IV, and V dyslipidemias. Important Safety Information Statin contraindications apply when ezetimibe is used with a statin: active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels; women who are pregnant or may become pregnant; and nursing mothers. Ezetimibe tablets are contraindicated in patients with a known hypersensitivity to any component of this product. Hypersensitivity reactions including anaphylaxis, angioedema, rash and urticaria have been reported with ezetimibe. Concurrent administration of ezetimibe with a specific statin or fenofibrate should be in accordance with the product labeling for that medication. Persistent elevations in hepatic transaminase were reported in controlled clinical combination studies of ezetimibe initiated concurrently with a statin. Cases of myopathy and rhabdomyolysis have been reported in patients treated with ezetimibe coadminstered with a statin; with ezetimibe monotherapy; and with the addition of ezetimibe to agents known to be associated with increased risk of rhabdomyolysis, such as fibrates. Risk for skeletal muscle toxicity increases with higher doses of statin, advanced age (greater than 65), hypothyroidism, renal impairment, and depending on the statin used, concomitant use of other drugs. Due to the unknown effects of the increased exposure to ezetimibe in patients with moderate to severe hepatic impairment, ezetimibe is not recommended in these patients. The most commonly reported adverse reactions (incidence greater than or equal to 2% and greater than placebo) in the ezetimibe monotherapy controlled clinical trials were: upper respiratory tract infection, diarrhea, arthralgia, sinusitis, and pain in extremity. The most commonly reported adverse reactions (incidence greater than or equal to 2% and greater than statin alone) in the ezetimibe plus statin controlled clinical trials were: nasopharyngitis, myalgia, upper respiratory tract infection, arthralgia, and diarrhea.