Pink Sheet 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

Amarin Says REDUCE-IT Results Are Off Limits To Omega-3 Supplement Claims

Executive Summary

REDUCE-IT results are limited to Amarin's Vascepa "and cannot be extrapolated to omega-3 products that are materially different based on, for example, composition, dosage, and regulatory status," pharma firm says in complaints against Coromega and Omax. Amarin seeks to stifle the omega-3 supplement firms despite First Amendment argument it made in successful litigation against FDA to make truthful statements about its products even though the information is not approved by the agency.

You may also be interested in...



Latest REDUCE-IT Results Bolster Case For Amarin's Vascepa Fish Oil Pill

Data may pave way for inclusion in heart disease treatment guidelines, ACC spokesperson says.

Amarin's REDUCE-IT Data For Vascepa May Be Game-Changing, But Not Without Controversy

CVOT results for Amarin's fish-oil pill show an unprecedented reduction in cardiovascular deaths. While questions have been raised about an LDL increase in the placebo group, an investigator says the overall results are too good to be explained by a well-known mineral oil effect.

'That's Huge, Folks': Amarin's Vascepa Cuts CV Risk By 25% On Top Of Statins

Cardiovascular outcomes data exceeded expectations for the fish oil pill, vindicating Amarin, which has fought long and hard for Vascepa's place in the CV disease prevention market. A filing based on REDUCE-IT is expected in early 2019.

Related Content

Topics

Related Companies

Latest News
UsernamePublicRestriction

Register

PS124190

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