FDA Calendar

Company Name Amarin Corp Plc
Drug Name Vascepa (sNDA)
Event Name FDA decision on expansion of Vascepa labeling based on the REDUCE-IT cardiovascular outcomes study
Event Date 12/28/2019
Outcome Date 12/13/2019
Outcome FDA Approves Amarin's Vascepa on Dec 13, 2019
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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