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FDA Looks To Placate Amarin, Duck Free Speech Decision

Law360, New York (June 8, 2015, 9:11 PM EDT) -- 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.

The letter was described by the FDA as an attempt to narrow the scope of a closely watched constitutional challenge that Amarin launched last month, with regulators saying they don’t object to most of what the Irish drugmaker wants to tell doctors...
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Case Information

Case Title

Amarin Pharma, Inc. et al v. United States Food & Drug Administration et al

Case Number



New York Southern

Nature of Suit

Other Statutory Actions


Paul A. Engelmayer

Date Filed

May 7, 2015

Law Firms


Government Agencies

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