US FDA Approves EPANOVA® (omega-3 carboxylic-acids)


Meredith Hemler

23 May 2014

By Rod Wooten, Executive Director, AstraZeneca

AstraZeneca recently announced that the US Food and Drug Administration (FDA) approved EPANOVA® (omega-3-carboxylic acids) as an adjunct to diet to lower triglyceride levels in adults with severe hypertriglyceridemia (triglyceride levels greater than or equal to 500 mg/dL).

Triglycerides are a type of lipid (fat) found in blood and an essential energy source for the body. Some people have severely high triglyceride levels, meaning they have too much fat in their blood, and that can lead to serious health complications.  Nearly four million American adults currently have severe hypertriglyceridemia and this figure continues to increase along with the incidence of associated conditions, such as obesity and diabetes.

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. It can be taken with or without food.

EPANOVA strengthens AstraZeneca’s existing portfolio of medicines and aligns with our strategic focus on scientific leadership. It reflects our ongoing commitment to developing treatment options and supporting health care providers, patients and caregivers.

EPANOVA® (omega-3-carboxylic acids)
Indication and Important Safety Information

EPANOVA is a prescription medicine used along with a low fat and low cholesterol diet to lower very high triglyceride (fat) levels in adults.

It is not known if EPANOVA changes your risk of having inflammation of your pancreas (pancreatitis).

It is not known if EPANOVA prevents you from having a heart attack or stroke.

Important Safety Information for EPANOVA® (omega-3-carboxylic acids) Capsules

  • Do not take EPANOVA if you are allergic to omega-3-carboxylic acids or any of the ingredients in EPANOVA
  • Tell your doctor if you are allergic to fish or shellfish, or if you are pregnant, breastfeeding or plan to become pregnant or breastfeed, as EPANOVA may not be right for you
  • Talk to your doctor about any current medical conditions you have and any medications you are taking, including prescription and over the counter medications, vitamins, and herbal supplements
  • Take EPANOVA exactly as your doctor tells you to take it and do not change your dose or stop taking EPANOVA without talking to your doctor
  • Your doctor should do blood tests to check your triglycerides, bad cholesterol (LDL-C) and liver function while you take EPANOVA
  • EPANOVA may cause serious side effects including increases in blood tests for liver function (ALT and AST) and for bad cholesterol (LDL-C), and possible allergic reactions if you are also allergic to fish or shellfish
  • The most common side effects of EPANOVA are diarrhea, upset stomach, abdominal pain or discomfort, and burping

Please see full Prescribing Information

2985606 Last Updated 5/14