Amarin's Vascepa buzzkill: FDA stalls label review with surprise panel meeting

Everything has gone according to plan for Amarin’s fish-oil pill Vascepa, with scripts booming and a fast-track review underway for a label update. Only one thing could put a damper on the drug’s rosy outlook: the FDA taking a closer look at its cardiovascular benefits.

And that's exactly what it plans to do.

The FDA will hold an advisory committee meeting Nov. 14 to review Amarin’s application to include a reduced risk of cardiovascular events in patients with abnormally high triglyceride levels on Vascepa’s label.