FDA Calendar

Company Name Amarin Corp Plc
Drug Name Vascepa (sNDA)
Event Name FDA panel to review expansion of Vascepa labeling based on the REDUCE-IT cardiovascular outcomes study
Event Date 11/14/2019
Outcome Date 11/14/2019
Outcome FDA panel voted unanimously (16-0) to recommend label expansion of Vascepa to reduce cardiovascular risk
Drug Status Vascepa (icosapent ethyl) is already approved as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (=500 mg/dL) hypertriglyceridemia.
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