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$AMRN $AMRN Sunday School Class for Sunday, August 15, 2021CaptBeer, published August 15, 2021
Topic: It's time to Exercise our First Amendment Rights.
Back in October 2013, the FDA ambushed Amarin in the infamous ADCOM meeting by moving the goal post of the ANCHOR Clinical Trial, and a few weeks later they rescinded the SPA, (which was basically an agreement to approve the 200-499 mg/dl new indication for VASCEPA®).
More than two years later (November 2015), a United States District Court ruled that Amarin may promote to healthcare professionals’ certain uses of Amarin's lead product, VASCEPA® (icosapent ethyl) capsules, that are not covered by current FDA-approved labeling for the drug so long as the promotion is “truthful and non-misleading”.
Can Amarin promote “truthful and non-misleading” information to HCP’s about VASCEPA® that are not covered by the current label?
Read all about it here: