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Amarin

Latest Headlines

Latest Headlines

Amarin case could unleash a flood of off-label promos

Off-label marketing has another legal stamp of approval, thanks to Amarin and its feisty pushback against the FDA. The Ireland-based pharma has been fighting for more than a year to promote its fish oil-derived pill for broader use, and it can now do so, even without FDA approval. And thanks to Amarin's legal maneuvering--and savvy choice of jurisdiction--any other drugmaker with truth on its side might soon do the same.

Amarin wins injunction against FDA in free speech case

On Friday, Amarin won what was being called a First Amendment free speech victory for drugmakers. It got a federal court to say the FDA cannot bar Amarin from discussing off-label use of its fish-oil drug Vascepa for a wider group of patients than it is approved for.

You're free to speak, FDA tells Amarin in bid to deflate free-speech suit

Pharma marketers are closely watching Amarin's lawsuit demanding the right to talk up the off-label uses for its cardiovascular drug Vascepa. After all, if the legal attack against FDA regulations succeeds, that gives credence to drugmakers' free speech argument--and could open up new worlds of drug promotion.

Why sue, FDA asks Amarin: You can spread the word on Vascepa already

Pharma marketers are closely watching Amarin's lawsuit demanding the right to talk up the off-label uses for its cardiovascular drug Vascepa. After all, if the legal attack against FDA regulations succeeds, that gives credence to drugmakers' free speech argument--and could open up new worlds of drug promotion.

Court grants Amarin long-awaited Vascepa exclusivity

Amarin has finally grabbed the 5-year marketing exclusivity for fish oil pill Vascepa that it's long been seeking.

FDA lawsuit in hand, Amarin plots a new Vascepa marketing strategy

Amarin styled its lawsuit against the FDA looking to lift the restrictions in place on its marketing case for the prescription-strength fish oil Vascepa as a First Amendment issue regarding free speech.

Secret doctor letter shows Amarin's true 'free speech' leanings

In case you're in doubt about why pharma is suddenly all about the First Amendment, here's some illuminating evidence. In a letter obtained by  CardioBrief 's Larry Husten, Amarin makes very clear that it sued FDA last week for marketing reasons, not out of love for the Bill of Rights.

Amarin sues FDA over 'free speech' issue the agency says it is ready to hash out

Irish drugmaker Amarin, which reported another quarterly loss today, has sued the FDA for curtailing its free speech, namely being able to discuss off-label uses of its omega-3 capsule Vascepa that might spur some sales.

Amarin grants Eddingpharm Greater China rights to Vascepa with clinical trial needed

China's Eddingpharm has been granted rights by Amarin to sell hypertriglyceridemia drug Vascepa icosapent ethyl in Greater China.

Amarin loses a second FDA appeal over omega-3 pill Vascepa

Amarin and its omega-3 pill have struck out with the FDA again. The Irish company said today that the agency has again turned down its appeal to reconsider its clinical data it hoped would help it win a label extension for Vascepa, dealing a new blow to its efforts and its financial well being. This FDA first rejected Amarin's request in January.