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Re: stangish post# 5469

Wednesday, 05/01/2013 7:14:01 AM

Wednesday, May 01, 2013 7:14:01 AM

Post# of 425918
Tia, here's the prodrug link for Icosapent Ethyl: "The drug product from Amarin contains a purified icosapent ethyl. Icosapent ethyl (ethyl eicosapentaenoic acid or ethyl-EPA) is the ethyl ester of EPA. Icosapent ethyl acts as a prodrug for EPA, as it is hydrolyzed enzymatically by esterases, particularly pancreatic lipase, to liberate the free acid EPA."

Pg 20 of the FDA's Medical Review for the Marine approval. The review documents started getting posted on March 6.

I haven't found a prodrug that the FDA hasn't awarded 5 yrs of exclusivity to.

Williams

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