Replies to post #22478 on Amarin Corp Plc (AMRN)

[labner]

labeling

DB,

Below are the links to the labeling. For further letters detailing the FDA's opinion, go to FDA drug page find lovaza and look for the link on label, letters, approvals. For Lovaza it would be the label change in 2009 and for Vascepa, under the same links, go to correspondence prior to approval and find the FDA's reasoning for not allowing the anchor information on the label. Essentially they state that the Anchor clinical trials were complete before Marine approval, bit the compilations would not be complete.

per earlier post 21665

Lovaza's labeling

includes study results from trig group (200-499) Vascepa does not. Therefore, doctors have more prescribing information on L vs V. I do not know if the differences in labeling information would effect insurance coverage. do you?

Vascepa label

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202057s002lbl.pdf

Lovaza label

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021654s039lbl.pdf

[BioChica]

Sorry, I do not remember posting that, but I have been taking Statins for 5-6 years. I have stopped the statins, and cutting down on the sodas and sugar. Increasing EPA consumption! My muscle cramps have stopped!