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FDA Advisory Panel: No Expanded Indication For Vascepa Without Outcomes Trial
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...
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FDA Throws More Cold Water On Amarin’s Hopes For Vascepa
Any remaining hopes for an expanded indication for Amarin’s Vascepa were largely dashed today by the FDA. Although it hasn’t yet rejected the proposed indication, the FDA today essentially overturned...
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