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Amarin Corp. PLC

Latest From Amarin Corp. PLC

Keeping Track: A Busy Week For Regenerative Medicine, A Surprise Priority Review For Vascepa, And Tazemetostat Aims For Accelerated Approval

The latest drug development news and highlights from our US FDA Performance Tracker.

Drug Review Regulation

NDI Guidance Could Drive Amarin's Gambit To Block Some Omega-3 Imports

Amarin's argument would swing on a finding by FDA that synthetics of omega-3s are not dietary ingredients. With such an FDA determination, a fair trade complaint to International Trade Commission about imports of omega-3 ingredients similar to the active ingredient in Amarin's Rx Vascepa theoretically would not be asking ITC to interpret FDA regulations by investigating imports of substances which FDA has not identified as noncompliant with its regulations.

Dietary Supplements FDA

Omega-3 Marketers Back Down On Comparisons To Amarin's Vascepa

Coromega Health and Omax will issue press releases explaining that the Amarin study each firm noted in previous releases was not relevant to omega-3 supplements. Releases subject to publication within three days of each settlement's finalization include six mentions of Amarin's Rx prescription triglyceride-lowering fish oil, Vascepa.

Dietary Supplements Clinical Trials

Court Tosses Amarin Fair Trade Complaint Against Omega-3 Imports

Majority opinion by Federal Circuit upheld International Trade Commission's decision and denied as moot Amarin's petition for order to compel a judicial or government officer or agency to perform a duty. Dissenting opinion not only agrees ITC acted correctly denying the firm's complaint, but also says the commission's decision wasn't appealable. Ropes & Gray attorneys suggest ruling provides guidance for additional fair trade complaints about FDA-regulated products.

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