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.
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.
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.
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.
- Therapeutic Areas
- Ethical Holdings
- Western Europe
- Parent & Subsidiaries
- Amarin Corp. PLC
- Senior Management
John F Thero, Pres. & CEO
Michael W Kalb, SVP, CFO
Craig B Granowitz, MD, PhD, SVP, CMO
Rami Daoud, SVP, Corp. Dev.
Steven Ketchum, PhD, SVP, R&D & CSO
Aaron Berg, SVP, Chief Commercial Officer
Derek Kalinowski, SVP, Commercial Supply Chain & Mfg. Ops.
Joseph T Kennedy, EVP, General Counsel & Strategic Initiatives
- Contact Info
Amarin Corp. PLC
Phone: (353) 1 6699 020
2 Pembroke House, St. 28-32
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