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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