CardioExchange Archive

May 6th, 2014

FDA Approves New Omega-3 Supplement

Larry Husten, PHD

The FDA has approved a new omega-3 supplement for the treatment of adults with severe hypertriglyceridemia, defined as triglyceride levels 500 mg/dL or higher. The drug, which will be marketed under the brand name of Epanova, is manufactured by AstraZeneca, which acquired the drug when it purchased Omthera Pharmaceuticals in 2013. AstraZeneca said that Epanova is the first omega-3 […]

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October 16th, 2013

FDA Advisory Panel: No Expanded Indication for Vascepa Without Outcomes Trial

Larry Husten, PHD

An FDA advisory panel today failed to recommend an expanded indication for Vascepa, the purified EPA fish-oil product from Amarin. Vascepa is currently indicated only for the relatively small number of people with severe hypertriglyceridemia (>500 mg/dL). The proposed new indication would have greatly expanded the patient population eligible to receive Vascepa to the 20% of […]

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July 27th, 2012

FDA Approves New Prescription Fish Oil Pill

Larry Husten, PHD

The FDA has approved a new prescription formulation of fish oils for treating very high triglyceride levels. The drug will be sold under the brand name Vascepa. According to Amarin, the manufacturer, it will be indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia (>500 mg/dL). Vascepa contains ultra-purified ethyl EPA, an […]

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