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Home » FDA Pulls Amarin’s SPA for Vascepa Trial, Casting Further Doubt on sNDA
FDA Pulls Amarin’s SPA for Vascepa Trial, Casting Further Doubt on sNDA
November 1, 2013
In a surprise move, the FDA has rescinded the special protocol assessment (SPA) for Amarin’s ANCHOR study of its heart drug Vascepa, the company’s third setback in two weeks after a disappointing advisory vote led Amarin to slash staff in order to stay afloat as it tries to win an expanded indication.