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FDA Approves Epanova (omega-3-carboxylic acids) for the Treatment of Severe Hypertriglyceridemia

Posted 6 May 2014 by Drugs.com

Tuesday, 6 May 2014 – AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Epanova (omega-3-carboxylic acids) as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia (triglyceride levels greater than or equal to 500 mg/dL). Epanova is the first FDA approved prescription omega-3 in free fatty acid form. The dosage of Epanova is 2 grams (2 capsules) or 4 grams (4 capsules), making it the first prescription omega-3 to have a dosing option as few as two capsules once a day, with or without food. “The FDA’s approval of Epanova is good news for the significant and growing population with severe hypertriglyceridemia as it offers physicians and their patients an important new treatment option that has been proven to be effective in clinical trials,” said Briggs Morrison, Executive Vice President, Global Medicines Devel ... Read more

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Teva Announces First Approval and Launch of Generic Lovaza Capsules in the United States

Posted 9 Apr 2014 by Drugs.com

JERUSALEM--(BUSINESS WIRE)--Apr. 8, 2014-- Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) announces the approval of the generic equivalent to Lovaza® (Omega-3-Acid Ethyl Esters Capsules, USP), in the United States. Teva believes it is first-to-file and thus far is the only Company to receive an approval from FDA. Teva plans to commence shipping immediately. Lovaza® Capsules, marketed by GlaxoSmithKline, had annual sales of approximately $1.1 billion in the United States, according to IMS data as of December 2013. About Teva Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world's leading g ... Read more

Related support groups: Lovaza, Fish Oil, Hypertriglyceridemia, Omega-3, Omacor, MaxEPA, Omega-3 Polyunsaturated Fatty Acids, Animi-3, Marine Lipid Concentrate, Super-EPA, Mi-Omega, Omega-500, Divista, EPA Fish Oil, Sea-Omega, Sea-Omega 70, Omega 3-6-9 Complex, TheraTears Nutrition, Proepa, TherOmega

Amarin Announces FDA Approval of Vascepa (icosapent ethyl) Capsules for the Reduction of Triglyceride Levels in Adult Patients With Severe Hypertriglyceridemia

Posted 27 Jul 2012 by Drugs.com

BEDMINSTER, N.J. and DUBLIN, Ireland, July 26, 2012 – Amarin Corporation plc, a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that the U.S. Food and Drug Administration (FDA) has approved Vascepa (icosapent ethyl) capsules (formerly known as AMR101) as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (TG greater than or equal to 500mg/dL) hypertriglyceridemia (very high triglycerides). Amarin submitted the New Drug Application (NDA) for the use of Vascepa in this indication in September 2011. "FDA approval of Vascepa represents the introduction of an important new treatment option for patients with severe hypertriglyceridemia. In Amarin's MARINE clinical trial, Vascepa demonstrated a statistically significant placebo-adjusted reduction in levels of ... Read more

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Lifestyle Changes Can Slash Blood Fat Levels, Experts Say

Posted 18 Apr 2011 by Drugs.com

MONDAY, April 18 – Healthy lifestyle changes can significantly lower elevated levels of triglycerides, a type of blood fat associated with heart disease and other health problems, says an American Heart Association scientific statement released Monday. About one-third (31 percent) of adults in the United States have elevated triglyceride levels, defined as more than 150 milligrams per deciliter (mg/dL). These levels can be lowered 20 percent to 50 percent by replacing unhealthy saturated fats with healthy unsaturated dietary fats, being physically active and losing excess weight, according to the statement authors, who analyzed more than 500 international studies from the past 30 years. "The good news is that high triglycerides can, in large part, be reduced through major lifestyle changes," statement committee chair Dr. Michael Miller, director of the Center for Preventive Cardiology ... Read more

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High Triglyceride Levels Linked to Increased Stroke Risk: Study

Posted 22 Feb 2011 by Drugs.com

TUESDAY, Feb. 22 – Men and women with high triglyceride levels are at an increased risk of ischemic stroke, which typically occurs when blood flow to the brain is blocked by a build-up of fatty deposits within blood vessels, a new Danish study contends. In fact, this stroke risk seems to be more pronounced for triglyceride fats than it is for cholesterol, even though cholesterol is currently the prime focus of current guidelines. These findings, the researchers said, suggest that triglyceride levels should be incorporated into stroke-prevention guidelines. "There might be an association between elevated triglyceride levels and increased stroke risk," said Dr. Tara Narula, a cardiologist with Lenox Hill Hospital in New York City. "All the guidelines really just focus on total cholesterol and LDL [low-density lipoprotein] cholesterol, and not on non-fasting triglycerides." The link ... Read more

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For Cholesterol Control, Experts Urge More Than Meds

Posted 29 Dec 2010 by Drugs.com

TUESDAY, Dec. 28 – Advances in medical science have made it easier than ever to lower dangerous cholesterol levels. A class of cholesterol-lowering drugs known as statins have proven particularly effective, reducing the risk for heart-related death by as much as 40 percent in people who have already suffered a heart attack, said Dr. Vincent Bufalino, president and chief executive of Midwest Heart Specialists and a spokesman for the American Heart Association. "People have said we need them in the drinking water because they are just so effective in lowering cholesterol," Bufalino said. But he and other doctors warn that when it comes to controlling cholesterol and enjoying overall health, nothing beats lifestyle changes, such as a heart-friendly diet and regular exercise. "Once we became a fast-food generation, it's just too easy to order it at the first window, pick it up at the ... Read more

Related support groups: High Cholesterol, Hypertriglyceridemia, High Cholesterol - Familial Heterozygous, High Cholesterol - Familial Homozygous, Hyperlipoproteinemia Type IIa (Elevated LDL), Hyperlipoproteinemia, Hyperlipoproteinemia Type IIb (Elevated LDL + VLDL), Hyperlipoproteinemia Type III (Elevated beta-VLDL + IDL), Hyperlipoproteinemia Type IV (Elevated VLDL), Hyperlipoproteinemia Type V (Elevated Chylomicrons + VLDL)

High Blood Fat Levels Common in Americans

Posted 23 Mar 2009 by Drugs.com

MONDAY, March 23 – Many Americans have higher-than-recommended levels of the blood fats called triglycerides, and most aren't making the lifestyle changes necessary to bring those levels down, a study finds. "Clearly, the focus in this country has been on cholesterol levels," said Dr. Earl S. Ford, with the U.S. Centers for Disease Control and Prevention and lead author of a report in the March 23 Archives of Internal Medicine. "But there are a fair number of studies that suggest that triglycerides have a role in cardiovascular disease." While just about everyone knows about the link between cholesterol and heart disease, few Americans seem concerned about triglycerides, which are the most common kind of fats in the body – and in food. Triglyceride levels aren't nearly as big a concern as cholesterol levels. While the journal report states that, "increasing evidence supports ... Read more

Related support groups: Hypertriglyceridemia, Prevention of Cardiovascular Disease

TriLipix Approved to Help Lower Cholesterol

Posted 16 Dec 2008 by Drugs.com

TUESDAY, Dec. 16 – The Abbott Laboratories drug TriLipix (fenofibric acid) has been approved by the U.S. Food and Drug Administration to help lower cholesterol. TriLipix is among a class of drugs called fibrates, and it can be used alone or in combination with a statin, such as Lipitor, Zocor or Crestor. The drug was studied in 2,698 people with so-called "mixed dyslipidemia," a condition characterized by above-normal levels of LDL (bad cholesterol) and triglycerides, and below-normal levels of HDL (good cholesterol). Clinical studies showed TriLipix used in combination with a statin helped people control all three lipids better than use of the statin alone, Abbott said in a news release. Common side effects of TriLipix included headache, heartburn, nausea, muscle aches, and increased levels of certain muscle and liver enzymes measured by blood tests. People with liver, gallbladder, or ... Read more

Related support groups: High Cholesterol, Hypertriglyceridemia

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Lovaza, Fish Oil, fenofibrate, Tricor, Trilipix, Omega-3, Antara, fenofibric acid, Vascepa, view more... Omacor, Lipofen, Lofibra, omega-3 polyunsaturated fatty acids, MaxEPA, Animi-3, Fenoglide, Marine Lipid Concentrate, Triglide, Fibricor, TheraTears Nutrition, TherOmega, Epanova, Vascazen, Divista, Omega 3-6-9 Complex, Sea-Omega 70, Super-EPA, Proepa, Sea-Omega, omega-3-carboxylic acids, icosapent ethyl, Omega-500, EPA Fish Oil, Lipidil EZ, Lipidil Supra, Lipidil Micro, Sea-Omega 30, Mi-Omega