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

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

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.http://www.drugs.com/newdrugs/fda-approves-epanova-omega-3-carboxylic-acids-severe-hypertriglyceridemia-4038.html?utm_source=ddc&utm_medium=email&utm_campaign=Today%27s+news+summary+-+May+6%2C+2014  AT DRUGS.COM

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LONDON, Sept. 18, 2013 – AstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for EpanovaTM, an investigational compound for the treatment for patients with severe hypertriglyceridaemia (triglyceride levels greater than or equal to 500mg/dL). The NDA submission for Epanova was filed by Omthera Pharmaceuticals, now a wholly-owned subsidiary of AstraZeneca, as a 505(b)(1) application in July 2013. The Prescription Drug User Fee Act (PDUFA) goal date for the FDA is 5 May 2014.http://www.pharmalive.com/fda-accepts-astrazeneca-nda-for-epanova