The FDA has finally reached a settlement in its long dispute with Amarin Corporation, manufacturer of the prescription fish oil product Vascepa. Last year a US judge ruled against the FDA. The settlement brings an end to the litigation and will permit Amarin to promote off-label usage of Vascepa as long as its statements are…
Amarin Begins Legal Off-Label Promotion Of Vascepa
September 10, 2015 by 4 Comments
Barely a month after a big victory in a federal court over the FDA, Amarin Pharma has started off-label promotion of Vascepa, its much-disputed prescription fish-oil product, Medical Marketing & Media reports. Vascepa was first approved by the FDA in 2012 as as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia (TG > 500mg/dL),…
The Amarin Decision: Free Speech Or Truthiness?
August 11, 2015 by 7 Comments
Amarin, which makes the prescription fish oil product Vascepa, won a big victory last Friday in its ongoing battle against the FDA. The bottom line: a federal judge ruled that the FDA can’t restrict Amarin’s first amendment right to disseminate off-label information about Vascepa providing it is neither false nor misleading. (You can read a detailed description…
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