HBW Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

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

Executive Summary

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.

You may also be interested in...



Amarin Critic's Petition Counters Its Bid To Stop Some Omega-3 Supplement Sales

"In a bid to have the right to purchase high-purity omega-3 supplements stripped from US consumers, Amarin attempted to circumvent the jurisdiction granted by Congress" to FDA, says Medical Research Collaborative in petition. The author also has reviewed Amarin's business results and has been critical of its stability.

Amarin: Complaint Of Unfair Competition From Omega-3 Supplements 'Ripe' For Supreme Court

As Amarin did in complaint to ITC for a fair trade investigation and appeal to Federal Circuit. it framed its petition for a writ of certiorari to Supreme Court as a compliant pharma firm that invested in research for approval of a drug asking federal agencies to enforce laws to stem competition from products it claims are labeled as supplements but should be deemed unapproved drugs.

Drug Innovation Needs Exclusivity For Some Natural Substances, PhRMA Recommends

In comments on VMS industry oversight, PhRMA recommends FDA adhere to clear regulations that determine whether substances are eligible for use as dietary ingredients. DSHEA makes clear that some dietary ingredients are not eligible for use VMS products.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

RS148798

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel