The Door Opens Wider For Drug Companies To Make Off-Label Claims

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…

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Amarin Begins Legal Off-Label Promotion Of Vascepa

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),…

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The Amarin Decision: Free Speech Or Truthiness?

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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Secret Letter To Doctors Shows That The Amarin Lawsuit Is About Marketing, Not Free Speech

A confidential letter sent by top Amarin executives to doctors clearly demonstrates that the primary motive for the lawsuit the company filed yesterday against the FDA has far more to do with marketing than free speech. Amarin said it is suing the FDA to gain the right to disseminate information about Vascepa that would support use…

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Amarin Says It Will Complete Cardiovascular Outcomes Trial For Its Fish Oil Pill

After nearly a year of uncertainty, Amarin  announced  its commitment to complete REDUCE-IT  (Reduction of Cardiovascular Events with EPA – Intervention Trial). The trial is designed to test the effects on cardiovascular outcomes of Vascepa, the company’s high EPA omega-3 prescription fish oil product, in people with moderately elevated triglyceride levels between 200-499 mg/dL. Last year the company…

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FDA Approves New Omega-3 Supplement

The FDA has approved a new omega-3 supplement for the treatment of adults with severe hypertriglyceridemia, defined as triglyceride levels 500 mg/dL or higher. The drug, which will be marketed under the brand name of Epanova, is manufactured by AstraZeneca, which acquired the drug when it purchased Omthera Pharmaceuticals in 2013. … Click here to read…

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FDA Throws More Cold Water On Amarin’s Hopes For Vascepa

Any remaining hopes for an expanded indication for Amarin’s Vascepa were largely dashed today by the FDA. Although it hasn’t yet rejected the proposed indication, the FDA today essentially overturned the foundation of the application, leaving little doubt as to the ultimate fate of the proposed new indication. As veteran biotechnology reporter Adam Feuerstein tweeted: “The…

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FDA Approves Vascepa, A New Fish Oil Pill From Amarin

The FDA has approved a new prescription formulation of fish oils for the treatment of very high levels of triglycerides. The news was  first reported by The Street reporter Adam Feuerstein. The drug will be sold under the brand name Vascepa. According to the company, it will be indicated as an adjunct to diet to reduce triglyceride…

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