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Thursday, 10/30/2014 12:25:23 PM

Thursday, October 30, 2014 12:25:23 PM

Post# of 428986
Daily Med Label Official FDA Label

MedlinePlus Web site, would seem to be official enough for marketing...no limit on Trig label Rx.

Can Amarin use this to market...it's from NIH in connection with FDA?

"Why is this medication prescribed?.Icosapent ethyl is used together with lifestyle changes (diet, weight loss, exercise) to reduce the amount of triglycerides (a fat-like substance) in your blood. Icosapent ethyl is in a class of medications called antilipemic or lipid-regulating agents. Icosapent ethyl may work by decreasing the amount of triglycerides and other fats made in the liver."
http://www.nlm.nih.gov/medlineplus/druginfo/meds/a613024.html

Overview
DailyMed provides trustworthy information about marketed drugs. DailyMed is the official provider of FDA label information (package inserts). This Web site provides a standard, comprehensive, up-to-date, look-up and download resource of medication content and labeling found in medication package inserts.

The National Library of Medicine (NLM) provides this as a public service and does not accept advertisements. The drug labeling information on this Web site is the most recent submitted to the Food and Drug Administration (FDA) and currently in use; it may include, for example, strengthened warnings undergoing FDA review or minor editorial changes. These labels have been reformatted to make them easier to read.

The drug labeling on this Web site may not be the labeling on currently distributed products or identical to the labeling that is approved. Drugs marked "OTC monograph final" or "OTC monograph not final" are not checked for conformance to the monograph. Drugs marked "unapproved" on this Web site have not been reviewed by FDA for safety and efficacy and their labeling has not been approved. For more information about unapproved drugs, visit Enforcement Activities by FDA.

Other information about drugs may also be available. NLM regularly processes data files uploaded from FDA's system and provides and maintains this Web site for the public to use in accessing the information. Additional information about medicines is available on NLM's MedlinePlus Web site.

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