Published: Fri, May 19, 2017
World | By Tasha Manning

Vascepa

Vascepa

E-EPA was the second fish-oil drug to be approved, after omega-3 acid ethyl esters (GlaxoSmithKline's Lovaza which was approved in 2004) and sales were not as robust as Amarin had hoped. The labels for the two drugs were similar, but doctors prescribed Lovaza for people who had triglycerides lower than 500 mg / dL based on some clinical evidence. Amarin wanted to actively market E-EPA for that population as well which would have greatly expanded its revenue, and applied to the FDA for permission to do so in 2013, which the FDA denied. In response, in May 2015 Amarin sued the FDA for infringing its First Amendment rights, and in August 2015 to judge ruled that the FDA could not "prohibit the truthful promotion of a drug for unapproved uses because it would violate the protection of free speech "The ruling left open the question of what the FDA would allow Amarin to say about E-EPA, and in March 2016 the FDA and Amarin agreed that Amarin would submit specific marketing material to the FDA for the FDA to review, and if the They disagreed on whether the material was truthful, they would seek to judge mediate. Keyword Suggestions

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