Vascepa Advisory Committee Is Latest Outpost In Product's Remarkable Regulatory Journey

 
• By Sue Sutter
  
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The last time representatives from Amarin and US FDA formally met in public, it was in court.

The US Food and Drug Administration's formal announcement that it would hold an advisory committee for Vascepa's expanded indication of cardiovascular risk reduction means that Amarin Corp. PLC is one step closer to a potentially significant new market. It also means that the company faces another big test in front of regulators with whom it has long had an adversarial relationship.

The fact that the advisory committee, scheduled for 14 November at the FDA's headquarters in Silver Spring, MD, is happening...

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