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|June 12, 2017 3:17 p.m.|
|Teva Announces Launch of Generic Zetia® in the United States|
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
“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
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
Ezetimibe tablets had annual sales of approximately
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.
For more information, please see accompanying Full Prescribing Information.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding the launch and potential benefits of Teva's generic version of Zetia®, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to:
and other factors discussed in our Annual Report on Form 20-F for the year ended December 31, 2016 (“Annual Report”) and in our other filings with the U.S. Securities and Exchange Commission (the “SEC”). 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 rely on these forward-looking statements. You are advised to consult any additional disclosures we make in our reports to the SEC on Form 6-K, as well as the cautionary discussion of risks and uncertainties under “Risk Factors” in our Annual Report. These are factors that we believe could cause our actual results to differ materially from expected results. Other factors besides those listed could also materially and adversely affect us. This discussion is provided as permitted by the Private Securities Litigation Reform Act of 1995.
1 Zetia® is a registered trademark of
Teva Pharmaceutical Industries Ltd.