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Amarin Pharma, Inc. et al v. United States Food & Drug Administration et al
Case Number:
1:15-cv-03588
Court:
Nature of Suit:
Judge:
Firms
Companies
Sectors & Industries:
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June 23, 2015
FDA Goes On Offense In Amarin's Free Speech Suit
Amarin Pharma Inc.'s constitutional challenge to restrictions on off-label marketing represents a "frontal assault" on the nation's drug approval process and is highly unlikely to succeed, the U.S. Food and Drug Administration told a New York federal judge on Tuesday.
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June 11, 2015
Big Pharma Torches FDA In Amarin's Free Speech Suit
The world's largest drugmakers on Thursday attacked the U.S. Food and Drug Administration's response to Amarin Pharma Inc.'s free speech challenge to limits on off-label promotion, telling a New York federal judge that the agency's proposed leeway is far too modest.
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June 08, 2015
FDA Looks To Placate Amarin, Duck Free Speech Decision
The U.S. Food and Drug Administration in a letter released Monday told Amarin Pharma Inc. it can make numerous off-label statements about fish oil medicine Vascepa, a move likely designed to short-circuit the company's potentially precedent-setting challenge to restrictions on free speech, experts say.
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May 26, 2015
Amarin Seeks Injunction Blocking FDA's Off-Label Muzzle
Amarin Pharma Inc. and doctors claiming the U.S. Food and Drug Administration has violated their First Amendment rights by restricting "truthful and non-misleading" statements about off-label uses for cardiovascular drug Vascepa asked a New York federal court on Friday to block the agency's enforcement.
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May 12, 2015
4 Issues To Watch In Amarin's Off-Label Marketing Suit
Amarin Pharma Inc.'s constitutional challenge to U.S. Food and Drug Administration restrictions on off-label marketing will explore important questions for False Claims Act suits and criminal punishment of drugmakers, including free speech rights and the FDA's duty to set clear rules before cracking down. Here are four important issues to watch.
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May 08, 2015
Amarin Says Off-Label Marketing Rules Flout 1st Amendment
Amarin Pharma Inc. sued the U.S. Food and Drug Administration on Thursday, arguing that the agency's curbs on drugmakers promoting drugs to doctors for unapproved uses amounts to a violation of their First Amendments rights to freely communicate truthful information.
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