Amarin Corp Plc (AMRN)

[HDGabor]

Sorry BB, but still could not find it:

Indication is the same since approval (with some wording change):

11/10/2004: 'Omacor® is indicated as an adjunct to diet to reduce very high (>= 500 mg/dL) triglyceride (TG) levels in adult patients.'

05/14/2014:'LOVAZA is a combination of ethyl esters of omega 3 fatty acids, principally EPA and DHA, indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (>=500 mg/dL) hypertriglyceridemia (HTG). (1)'

and Limitations of Use was included at least since 09/16/2009:
'Limitations of Use: The effect of LOVAZA on cardiovascular mortality and morbidity in patients with elevated triglycerides has not been determined. (1)'

tha last change was on 05/14/2014 as detailed in #28802

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#apphist

Where did you find the referred label update?