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…
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…
Secret Letter To Doctors Shows That The Amarin Lawsuit Is About Marketing, Not Free Speech
May 8, 2015 by Leave a Comment
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…
Amarin Says It Will Complete Cardiovascular Outcomes Trial For Its Fish Oil Pill
September 16, 2014 by Leave a Comment
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…
FDA Approves New Omega-3 Supplement
May 6, 2014 by Leave a Comment
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…
FDA Advisory Panel: No Expanded Indication For Vascepa Without Outcomes Trial
October 16, 2013 by Leave a Comment
An FDA advisory panel today failed to recommend an expanded indication for Vascepa, the purified EPA fish oil product from Amarin. Vascepa is currently indicated only for the relatively small number of people with severe hypertriglyceridemia (>500 mg/dl). The proposed new indication would have greatly expanded the patient population eligible to receive Vascepa to the 20%…
Why The FDA Probably Won’t Approve An Expanded Indication For Amarin’s Vascepa
October 14, 2013 by Leave a Comment
On Wednesday an FDA advisory panel will consider an expanded indication for Amarin Pharmaceuticals’ Vascepa, an EPA fish oil product currently indicated only for people with severe hypertriglyceridemia (>500 mg/dl). The new indication would greatly expand the patient population eligible to receive Vascepa, from the relatively few people with severe hypertriglyceridemia to the many millions…
Link To Prostate Cancer Brings More Bad News For Fish Oil Story
July 11, 2013 by Leave a Comment
Adding more confusion to an already fishy story, a new study has found a significant association between omega-3 fatty acids and the risk of prostate cancer. Although the linkage had been previously observed, the finding surprised the investigators, who wrote that “these findings contradict the expectation that high consumption of long-chain omega-3 fatty acids and low consumption…
Another Disappointing Study For Fish Oil Supplements
May 8, 2013 by 3 Comments
Another large study has failed to find any benefits for fish oil supplements. The Italian Risk and Prevention Study, published in the New England Journal of Medicine, enrolled 12,513 people who had not had a myocardial infarction but had evidence of atherosclerosis or had multiple cardiovascular risk factors. The patients were randomized to either a fish oil supplement…
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