FDA delays decision on Amarin 2nd chance

The U.S. Food and Drug Administration has delayed a decision on whether to reconsider its rescission of a special protocol agreement with Amarin Corp. plc that had bolstered hopes for the biotech's heart drug Vascepa.

Amarin, which has R&D headquarters in Groton, said it doesn't expect a significant delay in an FDA decision that was expected Wednesday. But the agency gave no new deadline, creating uncertainty among stockholders who sent Amarin shares tumbling more than 5 percent Thursday.

Amarin's hopes for quick FDA approval of Vascepa for an expanded market were dashed last year when an FDA committee recommended otherwise.

- Lee Howard


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