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exwannabe

10/29/13 6:55 PM

#19586 RE: nbm16yankees #19581

Can they pull the approval on Vascepa, which is being used for Marine indication?


No.

The main reason is that for those with trigs>500 the FDA still believes that these need to reduced regardless of CVD outcomes. I assume they can cause liver issues and other problems. This is as opposed to 150<trig<500 where they now think your doctor is an idiot for telling you to reduce the trig level.

High trigs>500 also might cause one to get a "fat head" and decide to reject the AMRN SPA :-)

Ok, back to serious mode.

The part about trig>500 being something that MUST be brought lower is the Marine indication, and nobody argues this. Furthermore, the FDA very rarely pulls a drug w/o safety problems.
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wmjenkins3938

10/29/13 6:56 PM

#19588 RE: nbm16yankees #19581

That way of thinking they'd have to pull a lot more than Vascepa, it's the only safe one