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An AdComm After All: Amarin's Vascepa Labeling Update Now Delayed By FDA

 
• By Jessica Merrill and Mandy Jackson

The US FDA informed the company it will convene an advisory committee meeting to review the REDUCE-IT sNDA for the proprietary fish oil pill, delaying the approval by at least three months and surprising investors.

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Amarin's Vascepa will get a US FDA advisory committee review. • Source: Shutterstock

The US Food and Drug Administration will convene its Endocrinologic and Metabolic Drugs Advisory Committee to review a critical labeling expansion for Amarin Corp. PLC's Vascepa (icosapent ethyl) for the treatment of severely high triglycerides, likely delaying approval of a supplemental new drug application (sNDA) based on the company's REDUCE-IT cardiovascular outcomes trial.

Amarin said after the stock market closed on 8 August that the US FDA informed the company it will hold...

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